Drug Recalls

KVK Tech Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750 mg/5 mL Due to Temperature Abuse

Date: 08/06/2021

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

KVK Tech has posted a lot recall of Atovaquone Oral Suspension 750 mg/5 mL.

About this recall:

KVK Tech is voluntarily recalling 2 lots of Atovaquone Oral Suspension, USP 750 mg/5 mL to the consumer level. The recall is based on customer complaints of unusual grittiness in the product, which KVK has determined was most probably caused by prolonged exposure of these product lots to extremely cold weather during shipment.

What this means to you:

Atovaquone is a prescription drug used to treat Pneumocystis jiroveci [Pneumocystis carinii] pneumonia, a type of pneumonia most likely to affect people with human immunodeficiency virus (HIV) in teenagers and adults, and is also used to prevent patients with weakened immune systems from contracting this type of pneumonia.

Exposure of atovaquone oral suspension to extremely low temperatures may result in changes to the effectiveness, appearance, taste, and thickness of the liquid. As the product is required to be protected from freezing temperatures, severely immunocompromised patients who receive less effective drug may not have their serious or life-threatening infection treated adequately. To date, KVK Tech is not aware of any adverse events associated with this problem.

The product is packaged in 8 oz. bottles (210 mL bottle with child-resistant cap) packaged in a carton with NDC # 10702-223-21; the affected lots are labeled 16653A and 16654A with both lots having expiration dates of December 2022. The lot numbers and expiration dates can be found on the right bottom side of the labels on the bottles.

Patients or caregivers who have bottles of recalled atovaquone should stop using and should return the product to KVK Tech at 110 Terry Drive, Newtown, PA 18940. KVK Tech will arrange to reimburse customers for their costs in purchasing the product.

Consumers with questions regarding this recall can contact KVK Tech at recall@kvktech.com215-579-1842 Ext: 6002, Monday through Friday, 8 am to 4:30 pm EST or via email at . Consumers should contact their physician or healthcare professional if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration. For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online.

KVK Tech Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750_mg/5 mL Due to Temperature Abuse

FDA Publish Date: 08/06/2021

KVK Tech is voluntarily recalling 2 lots of Atovaquone Oral Suspension, USP 750 mg/5 mL to the consumer level. The recall is based on customer complaints of unusual grittiness in the product, which KVK has determined was most probably caused by prolonged exposure of these product lots to extremely cold weather during shipment.

Exposure of atovaquone oral suspension to extremely low temperatures may result in changes to the effectiveness, appearance, taste, and thickness of the liquid. As the product is required to be protected from freezing temperatures, severely immunocompromised patients who receive less effective drug may experience inadequate treatment of serious and life-threatening infections. To date, KVK Tech is not aware of any adverse events associated with this problem.

Atovaquone is a prescription drug labeled to treat Pneumocystis jiroveci [Pneumocystis carinii] pneumonia, a type of pneumonia most likely to affect people with human immunodeficiency virus (HIV) in teenagers and adults, and is also used to prevent immunocompromised patients from contracting this type of pneumonia.

The product is packaged in 8 oz. bottles (210 mL bottle with child-resistant cap) packaged in a carton with NDC # 10702-223-21; the affected lots are labeled 16653A and 16654A, with both lots having expiration dates of December 2022. The lot numbers and expiration dates can be found on the right bottom side of the labels on the bottles.

The 2 lots of product were shipped to a single distributor, which has been notified as part of the recall. KVK Tech will be working with the distributor to ensure that the distributor’s customers return remaining inventory of the affected lots to KVK Tech for appropriate disposition. Patients or caregivers who have bottles of atovaquone affected by this recall should stop using and are requested to return the product to KVK Tech at 110 Terry Drive, Newtown, PA 18940, and KVK Tech will arrange to reimburse customers for their costs in purchasing the product.

Consumers with questions regarding this recall can contact KVK Tech at recall@kvktech.com215-579-1842 ext: 6002, Monday through Friday, 8 am to 4:30 pm EST or via email to . Consumers should contact their physician or healthcare professional if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1-800-332-1088 1-800-FDA-0178 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration.

Link to FDA recall notification.

Company Contact Information

Consumers:

KVK Tech

• 215-579-1842 Ext: 6002
• recall@kvktech.com

Media:

• Susan DiCroce
• (215) 579-1842 Ext: 1260

Product Details

For a listing of product photos: click here.

Pfizer Issues a Voluntary Nationwide Recall for 12 Lots of Chantix® (varenicline) Tablets Due to N-nitroso-varenicline Content

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Pfizer has posted a lot recall of Chantix (varenicline) tablets.

About this recall:

Pfizer is voluntarily recalling 2 lots of Chantix 0.5 mg tablets, 2 lots of Chantix 1 mg tablets, and 8 lots of the Chantix kit of 0.5 mg/1 mg tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level.

What this means to you:

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.

Chantix is a treatment to help patients quit smoking and is intended for short term use. People who smoke cigarettes are 15 to 30 times more likely to get lung cancer than people who do not smoke. Smoking is also associated with many other cancers. Chantix has a safety profile that has been established over 15 years of marketing authorization and through a robust clinical program. Pfizer believes the benefit/risk profile of Chantix remains positive. Patients currently taking Chantix should consult with their healthcare provider (HCP) to confirm if they received a recalled lot, and if appropriate, about alternative treatment options. To date, Pfizer has not received any reports of adverse events that have been related to this recall.

As communicated by the FDA, there is no immediate risk to patients taking Chantix. Patients who are taking this product should consult with their HCP or pharmacy to determine if they have received a recalled lot. Patients with the recalled lots should contact Stericycle at 888-276-6166 (Monday to Friday 8 am to 5 pm ET) for instructions on how to return their product and obtain reimbursement for their cost.

The NDC, lot number, expiration date, and presentation for recalled Chantix tablets are available at the link provided on the following page.

Pfizer’s Voluntary Nationwide Recall For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

Pfizer is voluntarily recalling 2 lots of Chantix 0.5 mg tablets, 2 lots of Chantix 1 mg tablets, and 8 lots of the Chantix kit of 0.5 mg/1 mg tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the company established Acceptable Daily Intake (ADI) level.

Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. The health benefits of stopping smoking outweigh the potential cancer risk from the nitrosamine impurity in varenicline. Nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.ⁱ

Chantix is a treatment to help patients quit smoking and is intended for short-term use. People who smoke cigarettes are 15 to 30 times more likely to develop lung cancer than people who do not smoke.ⁱⁱ Smoking is also associated with many other cancers.ⁱⁱⁱ Chantix has a safety profile that has been established over 15 years of marketing authorization and through a robust clinical program. Pfizer believes the benefit/risk profile of Chantix remains positive. Patients currently taking Chantix should consult with their healthcare provider (HCP) to confirm if they received an impacted lot, and if appropriate, about alternative treatment options. To date, Pfizer has not received any reports of adverse events that have been related to this recall.

As communicated by the FDA, there is no immediate risk to patients taking Chantix.^iv Patients who are taking this product should consult with their HCP or pharmacy to determine if they have received a recalled lot. Patients with the recalled lots should contact Stericycle at 888-276-6166 (Monday to Friday 8 am to 5 pm ET) for instructions on how to return their product and obtain reimbursement for their cost.

Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified their direct consignees by letter to arrange for return of any recalled product. Wholesalers and distributors with an existing inventory of the lots, listed in the table below, should stop use and distribution and quarantine the product immediately. If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Please conduct a sub-recall to those accounts and communicate this recall information immediately.

If you received free product through the Pfizer Patient Assistance Program (PAP) or the Pfizer Institutional Patient Assistance Program (IPAP), please check your stock immediately against the table below. If you have any of the affected product lots in your inventory, please follow the instructions on the press release for returning the product to Stericycle.

The NDC, lot number, expiration date, and presentation for recalled Chantix tablets are shown in the table below. The product lots were distributed nationwide to wholesalers and distributors in the United States (US) and Puerto Rico from June 2019 to June 2021.

Consumers with questions regarding this recall can contact the recall processor Eversana Life Science Services by phone at 1-888-304-5022, option 1; Monday to Friday, 8:00 am – 7:00 pm CDT. Consumers should contact their physician or HCP if they have experienced any problems that may be related to taking or using this drug product.

Customers with medical-related questions, who wish to report an adverse event, or quality issues about the recalled products should contact Viona by phone at 888-304-5011, Monday to Friday, 8:30 am – 5:30 pm EST.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
• Complete and submit the report Online
• Regular mail or fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the US FDA.

Link to FDA recall notification

Company Contact Information
Consumers:
Eversana Life Science Services
1-888-304-5022, option 1

Product Photos
Click here for product photos.

Viona Pharmaceuticals Issues Voluntary Nationwide Recall of Metformin HCl Extended-Release Tablets, 750 mg, Due to the Detection of NDMA Impurity

Date: 06/11/2021

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Viona Pharmaceuticals has posted a lot recall of Metformin HCl Extended-Release Tablets, USP 750 mg.

About this recall:
Viona is voluntarily recalling 2 lots of metformin hydrochloride (HCl) extended-release (ER) tablets, USP 750 mg to the retail level. The 2 lots of metformin HCl ER tablets, 750 mg have been found to contain levels of N-Nitrosodimethylamine (NDMA) above acceptable daily limits. This product was manufactured by Cadila Healthcare in November 2019 for United States (US) distribution by Viona.

What this means to you:
NDMA is classified as a substance that could cause cancer based on results from laboratory tests. NDMA is an environmental contaminant, found in water and foods (including meats, dairy products, and vegetables). Patients who have received recalled lots of metformin HCl ER tablets 750 mg are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment. According to the FDA, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their healthcare professionals (HCPs). To date, neither Viona, nor Cadila Healthcare have received any reports of adverse events related to this recall.

Metformin is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in plastic bottles of 100 tablets, under NDC 72578-036-01. The recalled lots (batches) of metformin HCl ER tablets 750 mg are listed at the link in the box on the following page. The product can be identified as white to off-white, capsule shaped, uncoated tablets, debossed with “Z”, “C” on one side and “20” on the other side.

Consumers with questions regarding this recall can contact the recall processor Eversana Life Science Services by phone at 1-888-304-5022, option 1; Monday to Friday, 8:00 am – 7:00 pm CDT. Consumers should contact their physician or HCP if they have experienced any problems that may be related to taking or using this drug product.

Customers with medical-related questions, who wish to report an adverse event, or quality issues about the recalled products should contact Viona by phone at 888-304-5011, Monday to Friday, 8:30 am – 5:30 pm EST.

For more information regarding this FDA Recall Notification, please refer to the FDA website here.

FDA contact information for reporting adverse events/quality complaints can be reached online here or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

Viona Pharmaceuticals Issues Voluntary Nationwide Recall of Metformin HCl Extended-Release Tablets, USP 750 mg, Due to the Detection of NDMA Impurity
FDA Publish Date: 06/11/2021

Viona is voluntarily recalling 2 lots of metformin hydrochloride (HCl) extended-release (ER) tablets, USP 750 mg to the retail level. The 2 lots of metformin HCl ER tablets, USP 750 mg have been found to contain levels of N-Nitrosodimethylamine (NDMA) above acceptable daily limits. This product was manufactured by Cadila Healthcare in November 2019 for United States (US) distribution by Viona.

Risk Statement:
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods (including meats, dairy products, and vegetables). Patients who have received impacted lots of metformin HCl ER tablets, USP 750 mg are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment. According to the Food and Drug Administration (FDA), it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their healthcare professionals (HCPs). Please visit the agency’s website for more information at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin. To date, neither Viona, nor Cadila Healthcare have received any reports of adverse events related to this recall.

The product is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in high-density polyethylene (HDPE) plastic bottles of 100 tablets, under NDC 72578-036-01. The impacted lots of metformin HCl ER tablets, USP 750 mg are listed in the table on the following page. The product can be identified as white to off-white, capsule shaped, uncoated tablets, debossed with “Z”, “C” on one side and “20” on the other side. Product was distributed nationwide to distributors.

Viona is notifying its customers by email and mail (FedEx Overnight) and is arranging for return of all recalled products to the recall processor at the following address:
Eversana Life Science Services
c/o Viona recall
ATTN: Returns Department
4580 S. Mendenhall Rd.
Memphis, TN 38141

Consumers with questions regarding this recall can contact the recall processor Eversana Life Science Services by phone at 1-888-304-5022, option 1; Monday to Friday, 8:00 am – 7:00 pm CDT. Consumers should contact their physician or HCP if they have experienced any problems that may be related to taking or using this drug product.

Customers with medical-related questions, who wish to report an adverse event, or quality issues about the recalled products should contact Viona by phone at 888-304-5011, Monday to Friday, 8:30 am – 5:30 pm EST.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
• Complete and submit the report Online
• Regular mail or fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the US FDA.

Link to FDA recall notification: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/viona-pharmaceuticals-inc-issues-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets

Company Contact Information
Consumers:
Eversana Life Science Services
1-888-304-5022, option 1

Product Photos
Click here for product photos.

Acella Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets) Due to Sub Potency

Date: 04/30/2021

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Acella Pharmaceuticals has posted a lot recall of NP Thyroid® (thyroid tablets).

About this recall:

Acella is voluntarily recalling certain lots listed at the link on the following page of 15 mg, 30 mg, 60 mg, 90 mg, and 120 mg NP Thyroid (levothyroxine [T4] and liothyronine [T3]) to the consumer level. The products are being recalled as routine testing has found these lots to be subpotent. The product contains less than 90% of the labeled amount of liothyronine (T3) and/or levothyroxine (T4).

 What this means to you:

The FDA is advising patients currently taking NP Thyroid from the recalled lots not to discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.

Patients being treated for hypothyroidism (underactive thyroid) who receive subpotent NP Thyroid may experience signs and symptoms of hypothyroidism which may include fatigue, sensitivity to cold, constipation, dry skin, puffy face, hair loss, decreased heart rate, depression, thyroid gland swelling, and/or unexplained weight gain or difficulty losing weight. Pregnant women who receive subpotent product could experience miscarriage or negative fetal outcomes. In elderly patients and those with underlying cardiac disease, cardiac problems related to abnormal thyroid levels could occur.

Consumers with questions about the recall can email Acella at recall@acellapharma.com or contact Acella representatives at 1-888-424-4341, Monday through Friday from 8:00 am – 5:00 pm ET. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. To best identify recalled product, the NDCs, product description, lot numbers, expiration dates, and product photos are listed at the link on the following page.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration (FDA).

For more information regarding this FDA Recall Notification, please refer to the FDA website. FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

Acella Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Sub Potency

FDA Publish Date: 4/30/2021

Acella is voluntarily recalling certain lots listed at the link on the following page of 15 mg, 30 mg, 60 mg, 90 mg, and 120 mg NP Thyroid®, Thyroid Tablets, USP (levothyroxine [T4] and liothyronine [T3]) to the consumer level. The products are being recalled as routine testing has found these lots to be subpotent. The product contains less than 90% of the labeled amount of liothyronine (T3) and/or levothyroxine (T4).

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid) who receive subpotent NP Thyroid may experience signs and symptoms of hypothyroidism which may include fatigue, sensitivity to cold, constipation, dry skin, puffy face, hair loss, decreased heart rate, depression, thyroid gland swelling, and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including the potential for early miscarriage, fetal thyroid problems, and/or impairments to fetal neural and skeletal development. In elderly patients and those with underlying cardiac disease, cardiac manifestations of thyroid problems may occur. To date, Acella has received 43 reports of serious adverse events that could possibly be related to this recall.

NP Thyroid is composed of levothyroxine and liothyronine and is used to treat hypothyroidism. The products subject to recall are packed in 100-count and 7-count bottles. Product images are provided at the link on the following page. To best identify recalled product, the NDCs, product description, lot numbers, and expiration dates are also listed at the link on the following page. These lots were distributed nationwide in the United States (US) to Acella’s direct accounts, including wholesalers, pharmacies, and healthcare offices.

Acella is proactively notifying its consignees to discontinue distribution of the recalled lots and is arranging for return of all recalled products. The FDA is advising patients currently taking NP Thyroid from the recalled lots not to discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.

Consumers with questions about the recall can email Acella at recall@acellapharma.com or contact Acella representatives at 1-888-424-4341, Monday through Friday from 8:00 am – 5:00 pm ET. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the US Food and Drug Administration (FDA).

Link to FDA recall notification

Company Contact Information

Consumers:

Acella Pharmaceuticals

• 1-888-424-4341
• recall@acellapharma.com

Product Details

For a listing of NDCs, lot numbers, expiration dates, and product photos: click here.

Bryant Ranch Prepack Issues Voluntary Nationwide Recall of Spironolactone 25 mg and 50 mg Tablets Due to Mislabeling with the Incorrect Strength

Date: 3/9/2021

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Bryant Ranch Prepack has posted a lot recall of spironolactone tablets.

About this recall:

Bryant Ranch Prepack is voluntarily recalling in total 47 bottles of spironolactone tablets (4 different lots) to the consumer level. The products have been found to be mislabeled, displaying the incorrect strength. Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets and prepackaged bottles of spironolactone 25 mg may contain spironolactone 50 mg tablets.

What this means to you:

A patient who takes spironolactone 25 mg instead of the prescribed spironolactone 50 mg may have an increase in blood pressure or increase in swelling due to excess fluid (edema). It is possible that patients could have a decrease in potassium, if taking half of the expected dose, which could lead to low potassium levels or hypokalemia, a condition associated with heart rhythm disorders. Additionally, patients who take spironolactone 50 mg instead of the prescribed spironolactone 25 mg could have an increase in potassium, which could be life threatening. Patients with decreased kidney function or those taking certain other medications (for example: RAAS inhibitors, such as lisinopril, captopril, and others) would be at increased risk. Consumers with questions regarding this recall can contact Bryant Ranch Prepack at 877-885-0882 Monday through Friday 6:30 am to 6 pm PST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online.
• Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

For more information regarding this FDA Recall Notification, please refer to the FDA website. FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

Bryant Ranch Prepack Issues Voluntary Nationwide Recall of Spironolactone 25 mg and 50 mg Tablets Due to Mislabeling with the Incorrect Strength

FDA Publish Date: 3/9/2021

Bryant Ranch Prepack is voluntarily recalling in total 47 bottles of spironolactone tablets (4 different lots) to the consumer level. The products have been found to be mislabeled, displaying the incorrect strength. Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets and prepackaged bottles of spironolactone 25 mg may contain spironolactone 50 mg tablets.

A patient who consumes spironolactone 25 mg instead of the prescribed spironolactone 50 mg may experience an elevation in blood pressure or increased swelling caused by excess fluid (edema) if taking the product chronically. It is possible that patients could experience a decrease in potassium if taking half of the expected dose which could lead to hypokalemia, a condition associated with cardiac arrhythmias. Furthermore, patients who consume spironolactone 50 mg instead of the prescribed spironolactone 25 mg could experience an increase in potassium which could be life-threatening. Patients with renal insufficiency or those taking concomitant reninangiotensin-aldosterone system (RAAS) inhibitors would be at increased risk. As of 3/9/2021, Bryant Ranch Prepack has not received any reports of adverse events related to this recall.

Spironolactone is indicated as a diuretic in the treatment of high blood pressure, heart failure, hypokalemia, and edema and is repackaged in 30, 60 and 90-count bottles. Lots included in recall:

The product can be identified by the following details on the label: medication name as listed above with strength in a bold black box and a red and blue “BRP Pharmaceuticals” logo. Photos of the labels are provided in the photo section linked below.

Bryant Ranch Prepack is notifying its distributors and customers by mail and is arranging for return of all recalled products. Distributors that have existing inventory of any of the lots listed in this recall should contact Bryant Ranch Prepack immediately.

Consumers with questions regarding this recall can contact Bryant Ranch Prepack at 877-885-0882 Monday through Friday 6:30 am to 6 pm PST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online.
• Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration (FDA).

Link to FDA recall notification

Company Contact Information Consumers:

• Bryant Ranch Prepack
• 877-885-0882

Product Photos: Click here for product photos.

Apotex Issues Nationwide Recall of Enoxaparin Sodium Injection Due to Mislabeling of Syringe Barrel Measurement Markings

Date: 2/3/2021

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information. Apotex has posted a lot recall of Enoxaparin Sodium Injection.

About this Recall:

Apotex is voluntarily recalling 2 batches of Enoxaparin Sodium Injection, USP to consumer level due to a packaging error resulting in some syringes barrels containing 150 mg/mL markings (corresponding to the 120 mg/0.8 mL strength) instead of 100 mg/mL markings (corresponding to the 100 mg/mL strength) on the syringe barrel and vice versa.

What this means to you:

Incorrect syringe barrel marking could result in inaccurate dose administration. In recalled batch CS008 (strength 100 mg/mL), patients could receive 3.75 mg of enoxaparin, instead of 3 mg of enoxaparin. In the other recalled batch (batch CT003, strength 120 mg/0.8 mL), patients could receive 2 mg of enoxaparin rather than 2.5 mg of enoxaparin. Accidentally taking too much drug may result in bleeding complications. Alternatively, if the dose administered is less than prescribed, blood clotting events could occur.

Enoxaparin sodium injection is used for the treatment of acute deep vein thrombosis (DVT), prevention of DVT which can lead to pulmonary embolism (PE), as well as for the prevention and treatment of certain cardiac events.

The recalled enoxaparin sodium injection can be identified by NDC numbers found on the carton and label of the product. The link on the following page provides these NDC numbers and additional details including the 2 recalled batch numbers.

Patients who have received either of the 2 impacted batches of enoxaparin sodium injection or have questions regarding this recall should contact their pharmacy. The FDA recommends patients not interrupt their therapy, immediately contact their healthcare provider for medical advice, and return the impacted product to Inmar Rx Solutions by contacting the number provided on the following page. 2— 0203-2021 Class 2 Enoxaparin Sodium Injection – Apotex Voluntary Nationwide Recall Consumers with the impacted units of Enoxaparin Sodium Injection, USP, please contact Inmar Rx Solutions (“Inmar”) at 1-855-667-8717, to receive a recall/return packet including the Recall Stock Response Form, or you may obtain this form from clsnetlink.com.

Consumers with questions regarding this recall can contact Apotex by phone at 1-800-706-5575 (8:30 am – 5 pm, EST Monday to Friday) or via email at UScustomerservice@Apotex.com.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online  or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

Apotex Issues Voluntary Nationwide Recall of Enoxaparin Sodium Injection, USP Due to Mislabeling of Syringe Barrel Measurement Markings

FDA Publish Date: 2/3/2021

Apotex is voluntarily recalling 2 batches of Enoxaparin Sodium Injection, USP to the consumer level due to a packaging error resulting in some syringes barrels containing 150 mg/mL markings (corresponding to the 120 mg/ 0.8 mL strength) instead of 100 mg/mL markings (corresponding to the 100 mg/mL strength) on the syringe barrel and vice versa. The packaging error was discovered during a customer complaint investigation. To date, Apotex has not received any reports of adverse events related to use of these two batches. The affected product is manufactured by Gland Pharma.

Health Hazard Assessment:

Incorrect syringe barrel marking could lead to miscalculation and inaccurate dose administration. In one recalled batch (batch CS008, strength 100 mg/mL), if a consumer used a 150 mg/mL concentration packaged in a barrel corresponding to a 100 mg/mL concentration, the patient could receive 3.75 mg of enoxaparin, instead of 3 mg of enoxaparin. In another recalled batch (batch CT003, strength 120 mg/0.8 mL), if a consumer used a 100 mg/mL concentration packaged in a barrel corresponding to a 150 mg/mL concentration, the patient would receive 2 mg of enoxaparin rather than 2.5 mg of enoxaparin. Accidental overdosage could result in bleeding complications. Alternatively, if the dose administered is less than prescribed, the patient may experience blood clotting events.

Enoxaparin sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT) which may lead to pulmonary embolism (PE), treatment of acute DVT, prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (MI) when concurrently administered with aspirin, and treatment of acute STsegment elevation MI.

The 2 impacted batches of enoxaparin sodium injection, USP were distributed by Apotex nationwide in the United States (US) to wholesalers and warehousing chains. Apotex is currently notifying its affected direct account wholesalers and warehousing chains via mail (FedEx Standard Overnight) by mailing a recall notification letter and is arranging for return of all recalled product.

The impacted enoxaparin sodium injection can be identified by NDC numbers found on the carton and label of the product. The table on the following page also provides additional details including the 2 recalled batch numbers.

Patients who have received either of the 2 recalled batches of enoxaparin sodium injection or have questions regarding this recall should contact their pharmacy. The FDA recommends individuals not interrupt their therapy, immediately contact their healthcare provider for medical advice, and return the impacted product to Inmar Rx Solutions by contacting the numbers provided in this press release.

Consumers with the affected units of enoxaparin sodium injection, please contact Inmar Rx Solutions (“Inmar”) at 1-855-667-8717, to receive a recall/return packet including the Recall Stock Response Form, or you may obtain this form from clsnetlink.com.

Consumers with questions regarding this recall can contact Apotex by phone at 1-800-706-5575 (8:30 am – 5 pm, EST Monday to Friday) or via email at UScustomerservice@Apotex.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Wholesalers, distributors, and retailers should return the recalled product to the place of purchase. Anyone with existing inventory should quarantine the recalled batches immediately. Customers who purchased the impacted product directly from Apotex can call Inmar Rx Solutions at 1-855-667-8717 (9:00 am – 5:00 pm, EST Monday to Friday), to arrange for their return.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online.
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the US Food and Drug Administration.

Link to FDA recall notification

Company Contact Information Consumers: Apotex Corp.

• 1-800-706-5575
• UScustomerservice@Apotex.com

Media:  Jordan Berman

• 1-416-749-9026
• jberman@apotex.com

Product Photos: Click here for product photos.

Nostrum Expands Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to NDMA Content

Date: 1/25/2021

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Nostrum Laboratories has posted a recall of 1 lot of metformin hydrochloride (HCl) extended release (ER) tablets in the strength of 750 mg.

About this Recall:

Nostrum is voluntarily recalling one (1) lot of metformin HCl ER tablets in the strength of 750 mg to the consumer level. This product is the generic equivalent to Glucophage® tablets.

The recalled metformin HCl ER 750 mg tablets have been found to contain levels of nitrosamine impurities above the acceptable daily intake limit of 96 ng/day. This is an expansion of the recall initially announced on November 2, 2020.

What this means to you:

N-Nitrosodimethylamine (NDMA) is classified as a substance that could cause cancer based on results from lab tests. NDMA is a known environmental contaminant and is found in water and foods (including meats, dairy products, vegetables).

Metformin is used as an add-on to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. The recalled metformin ER 750 mg tablets are packaged in plastic bottles of 100 tablets with NDC 29033-056-01.

The recalled tablets carry lot number MET200601 with expiration date 07/2022. The product can be identified as an off-white oblong tablet debossed with “NM7”.

Consumers should consult a healthcare professional (HCP) to obtain a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their HCP.

Consumers should contact their physician or HCP if they have experienced any problems that may be related to taking this drug product. Consumers with medical questions regarding this recall can contact Nostrum Medical Affairs at phone number 816-308-4941 or email quality@nostrumpharma.com Monday through Friday from 8 am – 5 pm CST. Consumers should contact their physician or pharmacy for further medical advice.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online  or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

Nostrum Expands Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to NDMA Content Above the Acceptable Daily Intake Limit

FDA Publish Date: 1/25/2021

Nostrum Laboratories is voluntarily recalling one (1) lot of metformin hydrochloride (HCl) extended release (ER) tablets, USP 750 mg (generic equivalent to Glucophage® tablets) to the consumer level. The metformin HCl ER tablets, USP 750 mg have been found to contain levels of nitrosamine impurities above the acceptable daily intake (ADI) limit of 96 ng/day as published in the Food and Drug Administration (FDA) Guidance Document issued September 2020. This is an expansion of the recall initially announced on November 2, 2020.

N-Nitrosodimethylamine (NDMA) is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods (including meats, dairy products, vegetables). To date, Nostrum has not received any reports of adverse events related to this recall.

The product is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in high density polyethylene (HDPE) bottles of 100 tablets, under NDC 29033- 056-01. The affected lot of metformin HCl ER tablets, USP 750 mg is listed in the table. The product can be identified as an off-white oblong tablet debossed with “NM7”. Metformin HCl ER tablets, USP 750 mg was distributed nationwide to wholesalers.

Product Description:

Metformin HCl Extended Release Tablets, USP 750 mg

NDC:

29033-056-01

Lot Number:

MET200601

Expiry Date:

07/2022

Nostrum is notifying its distributors by letter and is arranging for return of all recalled products. Pharmacies that have metformin HCl ER tablets, USP 750 mg which are being recalled should return to place of purchase. Consumers should consult a healthcare professional (HCP) to obtain a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their HCP. Consumers should contact their physician or HCP if they have experienced any problems that may be related to taking this drug product.

Consumers with medical questions regarding this recall can contact Nostrum Medical Affairs by phone at 816-308- 4941 or email quality@nostrumpharma.com Monday through Friday from 8 am – 5 pm CST.

Consumers should contact their physician or pharmacy for further medical advice. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online.
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) FDA.

Link to FDA recall notification

Company Contact Information Consumers: Nostrum Laboratories, Inc.

• Medical Affairs 816-308-4941
• quality@nostrumpharma.com

Product Photos: Click here for product photos

Fresenius Kabi Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection Due to the Presence of Particulate Matter

Date: 1/8/2021

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Fresenius Kabi has posted a lot recall of Ketorolac Tromethamine Injection, 30 mg/mL.

About this Recall:

Fresenius Kabi is voluntarily recalling a single lot of Ketorolac Tromethamine Injection, 30 mg/mL, in a 2 mL amber vial to the user level due to the presence of particulate matter.

What this means to you:

Ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. Particulate matter was found in reserve sample vials. No adverse event reports have been received for the recalled lot. Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and potentially life-threatening allergic reactions.

Customers with questions regarding this recall may contact Fresenius Kabi at 1-866-716-2459 Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. The NDC, lot number, and expiration date for the recalled product are available at the link below.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online  or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

Fresenius Kabi Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, Due to the Presence of Particulate Matter

FDA Publish Date: 1/8/2021

Fresenius Kabi is voluntarily recalling a single lot of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter. Particulate matter was found in reserve sample vials. No adverse event reports have been received for the recalled lot, which was produced and sold in 2019.

Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and potentially life-threatening allergic reactions.

Ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. The total combined duration of use of oral ketorolac tromethamine and ketorolac tromethamine injection should not exceed 5 days.

Listed below is a table of the recalled lot distributed nationwide in the United States to wholesalers, distributors, hospitals, and pharmacies between March 28, 2019 and September 3, 2019. An image of the label is also included at the link on the following page. Product Name/Product size ND

Product Name/Product size:

Ketorolac Tromethamine Injection, USP, 30mg / mL, 1 mL fill in a 2 mL amber vial

 NDC Number:

63323- 162-01

Product Code:

160201

 Batch Number:

6121083

 Expiration Date:

02/2021

 First Ship Date:

03/28/2019

 Last Ship Date:

09/03/2019

Fresenius Kabi is notifying its distributors and customers by letter and asking customers and distributors to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product. Distributors should notify their customers and direct them to quarantine and discontinue distributing or 2—0108-2021 Class 1 Ketorolac Tromethamine Injection – Fresenius Kabi Voluntary Nationwide Recall dispensing the affected lot, and to return the product to Fresenius Kabi. The recall letter and response form are available at https://www.fresenius-kabi.com/us/pharmaceutical-product-updates.

Customers with questions regarding this recall may contact Fresenius Kabi at 1-866-716-2459 Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Time.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report online.
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
• Or, contact Fresenius Kabi at 1-800-551-7176, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. or via email at: productcomplaint.USA@fresenius-kabi.com or adverse.events.USA@freseniuskabi.com.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration (FDA).

Link to FDA recall notification.

Company Contact Information Consumers: Fresenius Kabi

• 1-866-716-2459

Product Photos: Click here for product photos.

Nostrum Expands Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to NDMA Content

Date: 1/4/2021

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Nostrum Laboratories has posted a recall of 1 lot of metformin hydrochloride (HCl) extended release (ER) tablets in the strength of 750 mg.

About this Recall:

Nostrum is voluntarily recalling one (1) lot of metformin HCl ER tablets in the strength of 750 mg to the consumer level. This product is the generic equivalent to Glucophage® tablets. The recalled metformin HCl ER 750 mg tablets have been found to contain levels of nitrosamine impurities above the acceptable daily intake limit of 96 ng/day. This is an expansion of the recall initially announced on November 2, 2020.

What this means to you:

N-Nitrosodimethylamine (NDMA) is classified as a substance that could cause cancer based on results from lab tests. NDMA is a known environmental contaminant and is found in water and foods (including meats, dairy products, vegetables).

Metformin is used as an add-on to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. The recalled metformin ER 750 mg tablets are packaged in plastic bottles of 100 tablets with NDC 29033-056-01. The recalled tablets carry lot number MET200501 with expiration date 07/2022. The product can be identified as an off-white oblong tablet debossed with “NM7”.

Consumers should consult a healthcare professional (HCP) to obtain a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their HCP.

Consumers should contact their physician or HCP if they have experienced any problems that may be related to taking this drug product. Consumers with medical questions regarding this recall can contact Nostrum Medical Affairs at phone number 816-308-4941 or email quality@nostrumpharma.com Monday through Friday from 8 am – 5 pm CST. Consumers should contact their physician or pharmacy for further medical advice.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online  or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

Nostrum Expands Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to NDMA Content Above the Acceptable Daily Intake

Limit FDA Publish Date: 1/4/2021

Nostrum Laboratories is voluntarily recalling one (1) lot of metformin hydrochloride (HCl) extended release (ER) tablets, USP 750 mg (generic equivalent to Glucophage® tablets) to the consumer level. The metformin HCl ER tablets, USP 750 mg have been found to contain levels of nitrosamine impurities above the acceptable daily intake (ADI) limit of 96 ng/day as published in the Food and Drug Administration (FDA) Guidance Document issued September 2020. This is an expansion of the recall initially announced on November 2, 2020.

N-Nitrosodimethylamine (NDMA) is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods (including meats, dairy products, vegetables). To date, Nostrum has not received any reports of adverse events related to this recall.

The product is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in high density polyethylene (HDPE) bottles of 100 tablets, under NDC 29033- 056-01. The affected lot of metformin HCl ER tablets, USP 750 mg is listed in the table. The product can be identified as an off-white oblong tablet debossed with “NM7”. Metformin HCl ER tablets, USP 750 mg was distributed nationwide to wholesalers.

Product Description:

Metformin HCl Extended Release Tablets, USP 750 mg

NDC:

29033-056-01

Lot Number:

MET200501

Expiry Date:

07/2022

Nostrum is notifying its distributors by letter and is arranging for return of all recalled products. Pharmacies that have metformin HCl ER tablets, USP 750 mg which are being recalled should return to place of purchase. Consumers should consult a healthcare professional (HCP) to obtain a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their HCP. Consumers should contact their physician or HCP if they have experienced any problems that may be related to taking this drug product.

Consumers with medical questions regarding this recall can contact Nostrum Medical Affairs by phone at 816-308- 4941 or email quality@nostrumpharma.com Monday through Friday from 8 am – 5 pm CST. Consumers should contact their physician or pharmacy for further medical advice.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online.
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) FDA.

Link to FDA recall notification.

Company Contact Information Consumers: Nostrum Laboratories, Inc.

• Medical Affairs 816-308-4941
• quality@nostrumpharma.com

Product Photos: Click here for product photos.

Sunstar Americas Expands Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

Date: 12/28/2020

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information. Sunstar Americas has posted a market recall of Paroex® Chlorhexidine Gluconate Oral Rinse.

About this Recall:

Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products with an expiration date from 12/31/2020 – 9/30/2022 to the consumer level. The product may be contaminated with the bacteria Burkholderia lata. This is an expansion of the recall initially announced in October 2020.

What this means to you:

Use of the contaminated product may lead to a mouth infection and, potentially, an infection in the body that requires antibacterial treatment. In the most at-risk populations, the use of the contaminated product may lead to life-threatening infections, such as pneumonia and bacteremia.

Consumers with questions regarding this recall can contact SAI by phone at 1-800-528-8537 or email at us.pcr@us.sunstar.com Monday to Friday from 8 am to 5 pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

For more information regarding this FDA Recall Notification, please refer to the FDA website.  FDA contact information for reporting adverse events/quality complaints can be reached online  or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

Sunstar Americas Expands Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination FDA Publish

Date: 12/28/2020

Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products with an expiration date from 12/31/2020 – 9/30/2022 to the consumer level. The product may be contaminated with the bacteria Burkholderia lata. This is an expansion of the recall initially announced on October 27, 2020.

Use of the contaminated product in an immunocompetent host may lead to oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the contaminated product may result in life-threatening infections, such as pneumonia and bacteremia.

To date, 29 adverse events have been reported to the manufacturer related to this recall. Affected patients tested positive for Burkholderia lata infections, usually found in sputum cultures, while under treatment for other serious medical conditions. Use of the contaminated product in patients with pre-existing respiratory conditions, including in those with coronavirus disease 2019 (COVID-19), is particularly unsafe.

The prescription oral rinse product, available through healthcare professionals (HCPs) only, is indicated for use as part of a professional program for the treatment of gingivitis and is packaged as follows:

• 1789P GUM® Paroex® is distributed in cases each containing 6 amber bottles of 16 fluid ounce (473 mL) chlorhexidine rinse. The bottle has a childproof cap and a 15 mL metered dosage cup, is safety sealed, and is decorated with a multiple-panel wrap-around label.
• 1788P GUM® Paroex® is distributed in cases each containing 24 amber bottles of 4 fluid ounce (118.25 mL) chlorhexidine rinse. The bottle has a childproof cap, is safety sealed, and is decorated with a multiplepanel wrap-around label.

Paroex was distributed nationwide to dental offices, dental distributors, pharmaceutical wholesalers, dental schools, and pharmacies.

SAI is notifying its direct distributors and customers by USPS Priority mail and is arranging for return of all recalled products. Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately. Sunstar is committed to delivering safe, fully compliant products of the highest quality and is taking necessary steps to prevent future occurrence of this issue.

Consumers with questions regarding this recall can contact SAI by phone at 1-800-528-8537 or email at us.pcr@us.sunstar.com Monday through Friday from 8 am to 5 pm CST. Consumers should contact their physician or HCP if they have experienced any problems that may be related to using this drug product.

Affected products and lot numbers follow below:

• Product name: Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12%
• Size/ Form: 16 fl.oz. amber bottles
• NDC #: 052376-021-02
• Product Code: 1789P
• Lots Recalled: all lots with expiration date from December 31, 2020 through September 30, 2022

Product name: Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% o Size/ Form: 4 fl.oz. Amber Bottles o NDC #: 052376-021-04 o Product Code: 1788P o Lots Recalled: all lots with expiration date from December 31, 2020 through September 30, 2022 Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online.
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration (FDA).

Link to FDA recall notification.

Company Contact Information Consumers: Sunstar Americas

• 1-800-528-8537
• us.pcr@us.sunstar.com

Media: Greg Belair

• 847-794-4241
• Greg.belair@us.sunstar.com

Product Photos: Click here for product photos.

Avkare Issues Voluntary Nationwide Recall of Sildenafil 100 mg Tablets and Trazodone 100 mg Tablets Due to Product Mix-Up

Date: 12/9/2020

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Avkare has posted a lot recall of Sildenafil 100 mg tablets and Trazodone 100 mg tablets.

About this Recall:

Avkare is voluntarily recalling 1 lot of sildenafil 100 mg tablets and 1 lot of trazodone 100 mg tablets to the consumer level. These products have been recalled due to a product mix-up of the listed 2 separate products inadvertently packaged together during bottling at a third party facility.

What this means to you:

Unintended intake of sildenafil may pose serious health risks to those with underlying medical issues. For example, sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels. Patients with diabetes, high blood pressure, or heart disease often take nitrates.

Unintended intake of trazodone may result in adverse health consequences such as somnolence/sedation, dizziness, constipation, and blurred vision. These adverse events may be more concerning in elderly patients due to an increased risk for falls and driving impairment. To date, Avkare has not received any reports of adverse events related to this recall.

Sildenafil, the active ingredient in Viagra®, which is a phosphodiesterase-5 (PDE-5) inhibitor, is used for the treatment of erectile dysfunction (ED) and is packaged in 100 count bottles (NDC 42291-748-01). Trazodone is indicated for the treatment of major depressive disorder and is packaged in 1,000 count bottles (NDC 42291-834- 10). The recalled lots of sildenafil 100 mg tablet (lot 36884 with an expiration date of 03/2022) and trazodone hydrochloride 100 mg tablet (lot 36783 with an expiration date of 06/2022) were distributed to distributors and wholesalers, and then further distributed nationwide. Avkare has notified its distributors and customers and is arranging for return of all recalled product.

Consumers with questions regarding this recall can contact Avkare at 1-855-361-3993 Monday through Friday (8 am – 4 pm CST). Consumers should contact their physician or healthcare provider (HCP) if they have experienced any problems that may be related to taking or using these drug products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration (FDA).

For more information regarding this FDA Recall Notification, please refer to the FDA website. FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

Avkare Issues Voluntary Nationwide Recall of Sildenafil 100 mg Tablets and Trazodone 100 mg Tablets Due to Product Mix-Up

FDA Publish Date: 12/9/2020

Avkare is voluntarily recalling one (1) lot of sildenafil 100 mg tablets and one (1) lot of trazodone 100 mg tablets to the consumer level. These products have been recalled due to a product mix-up of the listed two separate products inadvertently packaged together during bottling at a third party facility.

Sildenafil, the active ingredient in Viagra®, which is a (PDE-5) inhibitor, is used for the treatment of erectile dysfunction (ED) and is packaged in 100 count bottles (NDC 42291-748-01). Trazodone is indicated for the treatment of major depressive disorder (MDD) and is packaged in 1,000 count bottles (NDC 42291-834-10). The impacted lots of sildenafil 100 mg tablet (lot 36884 with an expiration date of 03/2022) and trazodone hydrochloride 100 mg tablet (lot 36783 with an expiration date of 06/2022) were distributed to distributors and wholesalers, and then further distributed nationwide.

Avkare has notified its distributors and customers and is arranging for return of all recalled product of the listed lots. Distributors that have any of the product which is being recalled should contact Customer Service at Avkare at 1-855-361-3993 or email customerservice@avkare.com to arrange for the return of the product.

Consumers with questions regarding this recall can contact Avkare at 1-855-361-3993 Monday through Friday (8 am – 4 pm CST). Consumers should contact their physician or healthcare provider (HCP) if they have experienced any problems that may be related to taking or using these drug products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration (FDA).

Link to FDA recall notification.

Company Contact Information

Consumers: Customer Service at Avkare

• 1-855-361-3993
• customerservice@avkare.com

Media: Clifton Stanfill

• 931-908-2192

Product Photos

• Click here for product photos.

Torrent Issues Voluntary Nationwide Recall of Anagrelide Capsules Due to Dissolution Test Failure

Date: 12/9/2020

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Torrent Pharmaceuticals has posted a lot recall of anagrelide capsules.

About this Recall:

Torrent is voluntarily recalling 1 lot of anagrelide capsules to the consumer level due to dissolution test failure detected during routine quality testing.

What this means to you:

Failed dissolution can result in a slower rate and amount of drug release leading to less anagrelide available in the body. For seriously ill patients with increased platelet counts, less available anagrelide could increase the risk for clotting or bleeding events such as a heart attack or stroke which could be life-threatening. To date, Torrent has not received any reports of adverse events related to this recall.

Anagrelide is used to treat a blood cell disorder called thrombocythemia (also called thrombocytosis), which occurs when your body produces too many platelet cells.

As the risk of harm may be higher if the treatment is stopped immediately without any alternative treatment, patients should contact their pharmacist or physician who can advise them about an alternative treatment before returning their medication.

The product being recalled is listed below and packaged in bottles. It can be identified by checking the product name, manufacturer details, and batch or lot number on the bottle containing the product. NDC

Torrent is arranging for return of all recalled products to Qualanex.

Consumers with medical questions regarding this recall or to report an adverse event can contact Torrent at:

• 1-800-912-9561 (live calls received 8:00 am – 5:00 pm Eastern Time, Monday to Friday; voicemail available 8:00 am – 5:00 pm Eastern Time, Monday to Friday).
• Medinfo.Torrent@apcerls.com

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Any general questions regarding the return of this product should be directed to Qualanex at 1-888-424-4340 (live calls received 8 am – 5 pm Eastern Time, Monday to Friday).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online
•  Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration (FDA).

Torrent Issues Voluntary Nationwide Recall of Anagrelide Capsules, USP Due to Dissolution Test Failure

FDA Publish Date: 12/9/2020

Torrent is voluntarily recalling one (1) lot of anagrelide capsules, USP to the consumer level due to dissolution test failure detected during routine quality testing.

Failed dissolution can result in a slower rate and extent of drug release leading to less anagrelide available in the body. For seriously ill patients with elevated platelet counts, less available anagrelide could increase the risk of clotting or bleeding events such as a heart attack or stroke which could be life-threatening. To date, Torrent has not received any reports of adverse events related to this recall.

Anagrelide is used to treat a blood cell disorder called thrombocythemia (also called thrombocytosis), which occurs when your body produces too many platelets.

As the risk of harm may be higher if the treatment is stopped immediately without any alternative treatment, patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

 The product subjected to the recall is listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details, and batch or lot number on the bottle containing the product.

Anagrelide capsules, USP were distributed nationwide to Torrent’s wholesale distributor and retail customers. Torrent is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Torrent is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.

Consumers with medical questions regarding this recall or to report an adverse event can contact Torrent at:

• 1-800-912-9561 (live calls received 8:00 am – 5:00 pm Eastern Time, Monday to Friday; voicemail available 8:00 am – 5:00 pm Eastern Time, Monday to Friday).

• Medinfo.Torrent@apcerls.com

2—1209-2020 Class 2 Anagrelide Capsules – Torrent Voluntary Nationwide Recall

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Any general questions regarding the return of this product should be directed to Qualanex at 1-888-424-4340 (live calls received 8 am – 5 pm Eastern Time, Monday to Friday).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration.

Link to FDA recall notification: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/torrent-pharmaceuticals-limited-issues-voluntary-nationwide-recall-anagrelide-capsules-usp-due

Company Contact Information

Consumers: Torrent Pharmaceuticals Limited

• 1-800-912-9561
• Medinfo.Torrent@apcerls.com

Product Photos

Click here for product photos.

Recall of Regenecare® HA Hydrogel

Date: 12/02/2020

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

MPM Medical LLC has posted a lot recall of Regenecare® HA Hydrogel.

About this Recall:

MPM Medical is voluntarily recalling one (1) lot of Regenecare HA Hydrogel to the consumer level. Following two customer complaints of visible contamination, the product was found to be contaminated with the bacteria Burkholderia cepecia.

What this means to you:

Topical application of Regenecare HA Hydrogel contaminated with B. cepacia may result in local skin infections. For immunocompromised patients, including patients receiving chemotherapy and patients with cystic fibrosis, the skin infection is more likely to spread into the blood stream leading to life-threatening sepsis which can include symptoms such as fever, difficulty breathing, low blood pressure, fast heart rate, mental confusion, and possibly death. To date, MPM Medical has not received any reports of adverse events related to this recall.

Regenecare HA Hydrogel is an over-the-counter (OTC) product that contains 2% lidocaine and is used topically for temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations. It is packaged in 3 oz. plastic tubes and distributed in boxes of 12. The product can be identified by NDC 66977-107-03, and the lot number 41262 with expiration date 2021-01 debossed on the tube crimp as shown in the images provided at the hyperlink below. The recalled Regenecare HA Hydrogel lot (#41262) was distributed nationwide to wholesalers and healthcare facilities.

Patients in possession of the product which is being recalled should stop using. Consumers with questions regarding this recall can contact MPM Medical by phone at 1-800-232-5512 (toll-free) Monday through Friday between 7 AM and 5 PM CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product. For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online  or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2

MPM Medical Issues Voluntary Nationwide Recall of Regenecare® HA Hydrogel Due to Burkholderia cepecia Contamination

FDA Publish Date: 12/02/2020

MPM Medical is voluntarily recalling one (1) lot of Regenecare® HA Hydrogel to the consumer level. Following two customer complaints of visible contamination, the product was found to be contaminated with the bacteria Burkholderia cepecia.

Risk Statement: Topical application of Regenecare HA Hydrogel contaminated with B. cepacia may result in local skin infections. For immunocompromised patients, including patients receiving chemotherapy and patients with cystic fibrosis, the skin infection is more likely to spread into the blood stream leading to life-threatening sepsis which can include symptoms such as fever, difficulty breathing, low blood pressure, rapid heart rate, mental confusion, and possibly death. To date, MPM Medical has not received any reports of adverse events related to this recall.

Regenecare HA Hydrogel is an over-the-counter (OTC) product that contains 2% lidocaine and is used topically for temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations. It is packaged in 3 oz. plastic tubes and distributed in boxes of 12. The product can be identified by NDC 66977-107-03 and the lot number 41262 with an expiration date 2021-01 debossed on the tube crimp as shown in the images provided at the below hyperlink. The recalled Regenecare HA Hydrogel lot (#41262) was distributed nationwide to wholesalers and healthcare facilities.

MPM Medical is notifying its distributors and customers by first class mail, electronic mail, and phone call and is arranging for return of all recalled product. Patients and healthcare facilities in possession of this product which is being recalled should stop using and dispensing.

Consumers with questions regarding this recall can contact MPM Medical by phone at 1-800-232-5512 (toll-free) Monday through Friday between 7 AM and 5 PM CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

MPM Medical is committed to delivering safe, fully compliant products of the highest quality and is taking necessary steps to prevent future occurrence of this issue.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration.

Link to FDA website.

Company Contact Information

Consumers:

• MPM Medical, LLC
• 1-800-232-5512

Product Photos

• To view product photos, use link to FDA website

Nostrum Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 500 mg and 750 mg, Due to NDMA Content Above the Acceptable Daily Intake Limit

Date: 11/2/2020

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Nostrum Laboratories has posted a lot recall of metformin.

About this Recall:

Nostrum Laboratories is recalling 2 lots of Metformin Hydrochloride (HCl) Extended Release (ER) Tablets, USP 500 mg and 2 lots of Metformin HCl ER Tablets, USP 750 mg. These products are being recalled as they contain levels of nitrosamine impurities above the Acceptable Daily Intake (ADI) limit of 96 ng/day.

What this means to you:

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods (including meats, dairy products, and vegetables). Nostrum has not received any reports of adverse events related to this recall.

Metformin HCl ER tablets are indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Product is packaged in HDPE bottles of 100 tablets, with NDC 29033-055-01 (500 mg) or NDC 29033-056-01 (750 mg). The 500 mg product can be identified as an off-white oblong tablet debossed with “NM5”, and the 750 mg product can be identified as an off-white oblong tablet debossed with “NM7”. The impacted lots of Metformin HCl ER Tablets, USP 500 mg and 750 mg can be found at the FDA Recall Notification links on the following page.

Consumers should consult a healthcare professional (HCP) to obtain a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their HCP. Consumers should contact their physician or HCP if they have experienced any problems that may be related to taking this drug product.

Consumers with medical questions regarding this recall can contact Nostrum Medical Affairs at phone number 816-308-4941 or via email at quality@nostrumpharma.com Monday through Friday from 8 am to 5 pm CST. Consumers should contact their physician or pharmacy for further medical advice.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online.
• Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration.

Nostrum Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 500 mg and 750 mg, Due to NDMA Content Above the Acceptable Daily Intake Limit

Date: 11/2/2020

Nostrum Laboratories, Inc. is voluntarily recalling 2 lots of Metformin Hydrochloride (HCl) Extended Release (ER) Tablets, USP 500 mg and 2 lots of Metformin HCl ER Tablets, USP 750 mg to the consumer level. The Metformin HCl ER Tablets, USP 500 mg and 750 mg have been found to contain levels of nitrosamine impurities above the Acceptable Daily Intake (ADI) limit of 96 ng/day as published in the FDA Guidance Document issued September 2020.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods (including meats, dairy products, and vegetables). Nostrum has not received any reports of adverse events related to this recall.

Metformin HCl ER tablets are indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Product is packaged in HDPE bottles of 100 tablets, with NDC 29033-055-01 (500 mg) or NDC 29033-056-01 (750 mg). The affected Metformin HCl ER Tablets, USP 500 mg and 750 mg lots are listed in the table below.

Nostrum is notifying its distributors by letter and is arranging for return of all recalled products. Pharmacies that have Metformin HCl ER Tablets, USP 500 mg or 750 mg which are being recalled should return to the place of purchase. Consumers should consult a healthcare professional (HCP) to obtain a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their HCP. Consumers should contact their physician or HCP if they have experienced any problems that may be related to taking this drug product.

Consumers with medical questions regarding this recall can contact Nostrum Medical Affairs at phone number 816-308-4941 or via email at quality@nostrumpharma.com Monday through Friday from 8 am to 5 pm CST. Consumers should contact their physician or pharmacy for further medical advice.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online.
• Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration.

Links to FDA recall notifications

• 500 mg
• 750 mg

Company Contact Information

Consumers: Nostrum Laboratories, Inc. Medical Affairs

• 816-308-4941
• quality@nostrumpharma.com

Sunstar Americas Issues Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

Date: 10/28/2020

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Sunstar Americas, Inc. (SAI) has posted a lot recall of Paroex.

About this Recall:

SAI is voluntarily recalling specific lots of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% with an expiration date from 6/30/2022 to 9/30/2022 to the consumer level. This product is being recalled as it may be contaminated with the bacteria Burkholderia lata.

What this means to you:

Use of the contaminated product in a person with a normal immune response may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the contaminated product may result in life-threatening infections, such as pneumonia and bacteremia. To date, no adverse events have been reported related to this recall.

The prescription oral rinse product, available through healthcare providers (HCPs) only, is indicated for use as part of a professional program for the treatment of gingivitis and is packaged as follows:

• 1789P GUM® Paroex® is distributed in cases each containing 6 amber bottles of 16 fluid ounce (473 mL) chlorhexidine rinse. The bottle has a childproof cap and a 15 mL metered dosage cup, is safety sealed, and is decorated with a multiple-panel wrap-around label.
• 1788P GUM® Paroex® is distributed in cases each containing 24 amber bottles of 4 fluid ounce (118.25 mL) chlorhexidine rinse. The bottle has a childproof cap, is safety sealed, and is decorated with a multiple-panel wrap-around label.

The product can be identified as shown in the images linked here.

Paroex was distributed nationwide to dental offices, dental distributors, pharmaceutical wholesalers, dental schools, and pharmacies.

SAI is notifying its direct distributors and customers by USPS Priority mail and is arranging for return of all recalled products. Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately.

Consumers with questions regarding this recall can contact SAI by phone at 1-800-528-8537 or email at us.pcr@us.sunstar.com Monday through Friday from 8 am to 5 pm CST. Consumers should contact their physician or HCP if they have experienced any problems that may be related to using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Sunstar is committed to delivering safe, fully compliant products of the highest quality and is taking necessary steps to prevent future occurrence of this issue.

This recall is being conducted with the knowledge of the US Food and Drug Administration (FDA).

 For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

Sunstar Americas Issues Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

FDA Publish Date: 10/28/2020

Sunstar Americas, Inc. (SAI) is voluntarily recalling specific lots of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% with an expiration date from 6/30/2022 to 9/30/2022 to the consumer level. This product is being recalled as it may be contaminated with the bacteria Burkholderia lata.

Use of the defective product in an immunocompetent person may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia. To date, no adverse events have been reported related to this recall.

The prescription oral rinse product, available through healthcare providers (HCPs) only, is indicated for use as part of a professional program for the treatment of gingivitis and is packaged as follows:

• 1789P GUM® Paroex® is distributed in cases each containing 6 amber bottles of 16 fluid ounce (473 mL) chlorhexidine rinse. The bottle has a childproof cap and a 15 mL metered dosage cup, is safety sealed, and is decorated with a multiple-panel wrap-around label.
• 1788P GUM® Paroex® is distributed in cases each containing 24 amber bottles of 4 fluid ounce (118.25 mL) chlorhexidine rinse. The bottle has a childproof cap, is safety sealed, and is decorated with a multiple-panel wrap-around label.

The product can be identified as shown in the images linked at the bottom of this memo.

Paroex was distributed nationwide to dental offices, dental distributors, pharmaceutical wholesalers, dental schools, and pharmacies.

SAI is notifying its direct distributors and customers by USPS Priority mail and is arranging for return of all recalled products. Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately.

Consumers with questions regarding this recall can contact SAI by phone at 1-800-528-8537 or email at us.pcr@us.sunstar.com Monday through Friday from 8 am to 5 pm CST. Consumers should contact their physician or HCP if they have experienced any problems that may be related to using this drug product.

Affected products and lot numbers are listed below:

3—1028-2020 Class 2 Paroex – Sunstar Voluntary Nationwide Recall

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online

• Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Sunstar is committed to delivering safe, fully compliant products of the highest quality and is taking necessary steps to prevent future occurrence of this issue.

This recall is being conducted with the knowledge of the US Food and Drug Administration (FDA).

About Sunstar Americas Inc.

Sunstar Americas, Inc., a member of the Sunstar Group of companies, is a global organization headquartered in Switzerland that is a leader in the oral care industry and the manufacturer and distributor of the GUM and Butler Brands.

For more information:

us.pcr@us.sunstar.com Contact Sunstar: Phone: 1-800-528-8537 Email:

https://www.gumbrand.com/news-announcements Website:

Link to FDA recall notification: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sunstar-americas-inc-issues-voluntary-nationwide-recall-paroexr-chlorhexidine-gluconate-oral-rinse

Company Contact Information

Consumers: Sunstar Americas, Inc.

• 1-800-528-8537
• us.pcr@us.sunstar.com

Product Photos

• Click here for product photos

Marksans Pharma Issues Expansion of Voluntary Nationwide Recall of Metformin HCl ER Tablets, USP 500 mg & 750 mg, Due to the Detection of NDMA

Date: 10/5/2020

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Marksans Pharma has posted a lot recall of metformin.

About this Recall:

Marksans Pharma is voluntarily expanding its earlier initiated recall on June 5, 2020 to include an additional 76 unexpired lots of Metformin Hydrochloride (HCl) Extended-Release (ER) Tablets, USP 500 mg and 750 mg to the consumer level. Marksans performed N-Nitrosodimethylamine (NDMA) testing of unexpired identified marketed lots and observed that NDMA content in some lots was exceeding the acceptable daily intake (ADI) limit of 96 ng/day, therefore, out of an abundance of caution, an additional 76 lots are being recalled.

What this means to you:

NDMA is classified as a substance that could cause cancer based on results from laboratory tests. NDMA is a known environmental contaminant found in water and foods (such as meats, dairy products, and vegetables). Marksans has not received any reports of adverse events that have been related to this recall.

Metformin HCl ER Tablets, USP 500 mg and 750 mg are indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. It is packaged in bottles with the following NDC numbers in different packing configurations.

Metformin HCl ER Tablets, USP 500 mg:

• 90 counts: 49483-0623-09
• 100 counts: 49483-0623-01
• 500 counts: 49483-0623-50
• 1,000 counts: 49483-0623-10

Metformin HCl ER Tablets, USP 750 mg:

• 100 counts: 49483-0624-01

The affected Metformin HCl ER Tablets, USP 500 mg, are white to off white, capsule shaped, biconvex tablets, debossed with ‘101’ on one side and plain on the other side. The impacted Metformin HCl ER Tablets, USP 750 mg, are white to off white, capsule shaped, biconvex tablets, debossed with ‘102’ on one side and plain on the other side.

For a complete listing of recalled lot numbers and expiration dates, view the FDA recall notification: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/marksans-pharma-limited-issues-expansion-voluntary-nationwide-recall-metformin-hydrochloride.

Consumers taking these recalled product lots of metformin ER tablets are instructed by the FDA to continue taking it, until a doctor or pharmacist gives them a replacement or an alternative treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their healthcare professional (HCP). Consumers should contact their physician or HCP if they have experienced any problems that may be related to taking or using this drug product.

Consumers with questions regarding this recall and return can contact Ms. Irene McGregor (Vice President, Regulatory Affairs) of Time-Cap Labs by phone number 631-753-9090, ext. 160, Monday to Friday 8 am to 5 pm EST or by e-mail at imcgregor@timecaplabs.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Link to initial FDA recall notification

Link to expanded FDA recall notification

For more information regarding this FDA Recall Notification, please refer to the FDA website

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

2020 Magellan Rx Management, LLC. All rights reserved.

Marksans Issues Expansion of Voluntary Nationwide Recall of Metformin HCl ER Tablets, USP 500 mg & 750 mg, Due to the Detection of NDMA

FDA Publish Date: 10/5/2020

Marksans Pharma is voluntarily expanding its earlier initiated recall on June 5, 2020 to include an additional 76 unexpired lots of Metformin Hydrochloride (HCl) Extended-Release (ER) Tablets, USP 500 mg and 750 mg to the consumer level. Marksans performed N-Nitrosodimethylamine (NDMA) testing of unexpired identified marketed lots and observed that the NDMA content in some lots was exceeding the acceptable daily intake limit (ADI) of 96 ng/day, therefore, out of an abundance of caution, an additional 76 lots are being recalled.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant found in water and foods (such as meats, dairy products, and vegetables). Marksans has not received any reports of adverse events related to this recall.

Metformin HCl ER Tablets, USP 500 mg and 750 mg are indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. It is packaged in HDPE bottles with the following NDCs in different packing configurations:

Metformin HCl ER Tablets, USP 500 mg:

• 90 counts: 49483-0623-09
• 100 counts: 49483-0623-01
• 500 counts: 49483-0623-50
• 1,000 counts: 49483-0623-10

Metformin HCl ER Tablets, USP 750 mg:

• 100 counts: 49483-0624-01

The affected Metformin HCl ER Tablets, USP 500 mg, are white to off white, capsule shaped, biconvex tablets, debossed with ‘101’ on one side and plain on the other side. The impacted Metformin HCl ER Tablets, USP 750 mg, are white to off white, capsule shaped, biconvex tablets, debossed with ‘102’ on one side and plain on the other side.

For a complete listing of recalled lot numbers and expiration dates, view the FDA recall notification: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/marksans-pharma-limited-issues-expansion-voluntary-nationwide-recall-metformin-hydrochloride.

Metformin HCl ER Tablets, USP 500 mg and 750 mg were distributed by Time-Cap Labs nationwide in the United States (US) to wholesalers who further distributed to pharmacies. Marksans is notifying its distributors and customers by issuing a notification letter and press release and is arranging for return/replacement of recalled product lots. Distributors and customers that have affected lots of metformin HCl ER tablets that are being recalled should return to the place of purchase. The lot number can be located on the side panel of bottle labels as well as shipper/case labels.

Consumers taking these recalled product lots of metformin ER tablets are instructed by the FDA to continue taking it, until a doctor or pharmacist gives them a replacement or an alternative treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their healthcare professional (HCP). Consumers should contact their physician or HCP if they have experienced any problems that may be related to taking or using this drug product. Consumers with questions regarding this recall and return can contact Ms. Irene McGregor (Vice President, Regulatory Affairs) of Time-Cap Labs by phone number 631-753-9090, ext. 160, Monday to Friday 8 AM to 5 PM EST or by e-mail at imcgregor@timecaplabs.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online

• Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the US Food and Drug Administration (FDA).

• Link to initial FDA recall notification
• Link to expanded FDA recall notification

Company Contact Information

Consumers: Ms. Irene McGregor (Vice President, Regulatory Affairs) of Time-Cap Labs, Inc.

• 631-753-9090; ext. 160
• imcgregor@timecaplabs.com

Product Photos

• Click here for product photos

Sun Pharma Issues Voluntary Nationwide Recall of Riomet ER™ (metformin HCl for ER oral suspension) due to NDMA

Date: 9/23/2020

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Sun Pharma has posted a lot recall of Riomet ER™ (metformin hydrochloride [HCl] for extended-release [ER] oral suspension).

About this Recall:

Sun Pharma is voluntarily recalling 1 lot of Riomet ER (metformin HCl for ER oral suspension), 500 mg per 5 mL, to the consumer level. The reason for the recall is due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the acceptable daily intake (ADI) limit established by the United States (US) Food and Drug Administration (FDA).

NDMA is classified as a substance that could cause cancer based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods, such as meats, dairy products, and vegetables. To date, Sun Pharma has not received any reports of adverse events related to this recall.

What this means to you:

Patients taking Riomet ER (metformin HCl for ER oral suspension), 500 mg per 5 mL are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the US FDA, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their healthcare professionals (HCPs). Please visit the agency’s website for more information at https://www.fda.gov/drugs/drug-safety-andavailability/fda-updates-and-press-announcements-ndma-metformin.

Riomet ER (metformin HCl for ER oral suspension) is a prescription oral medication indicated as an add-on to diet and exercise to improve blood glucose control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Riomet ER, when reconstituted, is packaged in a 16 oz. (473 mL) round bottle. Each carton contains 1 bottle of drug pellets, 1 bottle of diluent, and 1 dosing cup.

The product can be identified by the bottles or carton labeled as Riomet ER containing the specific NDC, lot number, and expiration date found at the FDA Recall Notification link below.

Consumers with questions regarding this recall can contact Sun Pharma by calling 1-800-818-4555 Monday through Friday between 8:00 am to 5:00 pm EST or e-mailing drug.safetyUSA@sunpharma.com. Consumers should contact their physician or HCP if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

Sun Pharma Issues Voluntary Nationwide Recall of Riomet ER™ (metformin HCl for ER oral suspension) due to NDMA

FDA Publish Date: 9/23/2020

Sun Pharma is voluntarily recalling 1 lot of Riomet ER™ (metformin hydrochloride [HCl] for extended-release [ER] oral suspension), 500 mg per 5 mL, to the consumer level. The reason for the recall is due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the acceptable daily intake (ADI) limit established by the United States (US) Food and Drug Administration (FDA).

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods, such as meats, dairy products, and vegetables. To date, Sun Pharma has not received any reports of adverse events related to this recall.

Riomet ER (metformin HCl for ER oral suspension) is a prescription oral medication indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Riomet ER, when reconstituted, is packaged in a 16 oz. (473 mL) round bottle. Each carton contains 1 bottle of drug pellets, 1 bottle of diluent, and 1 dosing cup. The affected Riomet ER is the following lot:

The product can be identified by the bottles or carton labeled as Riomet ER (metformin HCl for ER oral suspension), containing the specific lot number and expiration date referenced above or on the product photos linked below. The product was distributed nationwide to wholesale customers.

Sun Pharma is notifying its distributors and customers through its third-party Recall Coordinator (Inmar), via FedEx standard overnight shipping and will arrange for return of all recalled products.

Distributors and retailers that have Riomet ER (metformin HCl for ER oral suspension), which is being recalled, should stop distributing and return it to the place of purchase or as directed in the recall notification.

Patients taking Riomet ER (metformin HCl for ER oral suspension), 500 mg per 5 mL are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the US FDA, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their healthcare professionals (HCPs). Please visit the agency’s website for more information at https://www.fda.gov/drugs/drug-safety-andavailability/fda-updates-and-press-announcements-ndma-metformin.

Consumers with questions regarding this recall can contact Sun Pharma by calling 1-800-818-4555 Monday through Friday between 8:00 am to 5:00 pm EST or e-mailing drug.safetyUSA@sunpharma.com. Consumers should contact their physician or HCP if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the US FDA.

Link to FDA recall notification

Company Contact Information

Consumers: Sun Pharma

• 1-800-818-4555
• Drug.safetyUSA@sunpharma.com

Media: Vinita Alexander

• 1-609-720-8197
• vinita.alexander@sunpharma.com

Product Photos

• Click here for product photos

FDA Alerts of Perrigo’s Voluntary Albuterol Inhaler Recall

Date: 9/21/2020

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Perrigo has posted a market recall of albuterol inhalers.

About this Recall:

The United States Food and Drug Administration (FDA) is alerting healthcare professionals (HCPs) and patients of a voluntary recall of all unexpired albuterol sulfate inhalation aerosol manufactured by Catalent Pharma for Perrigo due to possible clogging of the inhaler resulting in patients not receiving enough or any medicine.

What this means to you:

The albuterol inhaler delivers medication into the body through the airway and lungs, where it opens the airways to treat asthma and other conditions, such as chronic obstructive pulmonary disease (COPD). Patients could experience health risks if their rescue albuterol inhaler malfunctions and does not relieve symptoms in an emergency situation. The FDA urges patients to continue using the inhaler they have on hand.

Additionally, the FDA advises patients to:

• immediately seek emergency care if needed;
• use their Perrigo inhaler they have on hand, as needed and as directed by a doctor;
• have extra inhalers or an alternative treatment available in case of malfunction, as some of these recalled inhalers stop working after several uses; and
•  contact their HCP or pharmacist with questions.

FDA reminds HCPs and patients that albuterol inhalers are available through additional manufacturers. Perrigo informed the FDA it had received several thousand complaints about its product. Most of the complaints were for clogging and failure to dispense enough medicine. The manufacturer of Perrigo’s albuterol inhaler, Catalent, stopped producing and distributing the albuterol inhaler products on August 21, 2020 and is currently investigating the malfunction.

The agency asks HCPs and patients to report unexpected side effects or quality problems associated with albuterol inhalers to FDA’s MedWatch Adverse Event Reporting program:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

FDA Alerts of Perrigo’s Voluntary Albuterol Inhaler Recall

FDA Publish Date: 9/21/2020

The United States (US) Food and Drug Administration (FDA) is alerting healthcare professionals (HCPs) and patients of a voluntary recall of all unexpired albuterol sulfate inhalation aerosol manufactured by Catalent Pharma for Perrigo, due to possible clogging of the inhaler resulting in patients not receiving enough or any medicine. This recall is to the retail level. The FDA urges patients to continue using the inhaler they have on hand.

The albuterol inhaler delivers medication into the body through the airway and lungs, where it opens the airways to treat asthma and other conditions, such as chronic obstructive pulmonary disease (COPD). Patients could experience health risks if their rescue albuterol inhaler malfunctions and does not relieve symptoms in an emergency situation.

The FDA is advising patients to:

• immediately seek emergency care if needed;
• use their Perrigo inhaler they have on hand, as needed and as directed by a doctor;
• have extra inhalers or an alternative treatment available in case of malfunction, as some of these recalled inhalers stop working after several uses; and
• contact their HCP or pharmacist with questions.

FDA reminds HCPs and patients that albuterol inhalers are available through additional manufacturers.

Perrigo informed the FDA it had received several thousand complaints about its product. Most of the complaints were for clogging and failure to dispense enough medicine. The manufacturer of Perrigo’s albuterol inhaler, Catalent, stopped producing and distributing the albuterol inhaler products on August 21, 2020 and is currently investigating the malfunction.

The agency asks HCPs and patients to report unexpected side effects or quality problems associated with albuterol inhalers to FDA’s MedWatch Adverse Event Reporting program:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.

Link to FDA recall notification

RLC Labs Issues Voluntary Nationwide Recall of All Lots of Nature-Throid® and WP Thyroid® Due to Sub Potency

Date: 9/3/2020

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

RLC Labs has posted a recall of all lots of Nature-Throid and WP Thyroid.

About this Recall:

RLC Labs is voluntarily recalling a total of 483 lots of Nature-Throid and WP Thyroid in all strengths and all counts that are currently within expiration. The products are being recalled as testing of samples from 6 lots by the United States (US) Food and Drug Administration (FDA) found the samples to contain lower levels of drug than expected or to be sub potent. The product may have as low as 87% of the labeled amount of thyroid hormones, liothyronine (T3) or levothyroxine (T4).

What this means to you:

Patients being treated for hypothyroidism (underactive thyroid), who receive recalled Nature-Throid or WP Thyroid, may experience signs and symptoms of underactive thyroid which may include fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland, and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism. In elderly patients and patients with underlying cardiac disease, toxic cardiac manifestations of abnormal thyroid levels may occur. RLC Labs has not received any reports of adverse events related to this recall.

Nature-Throid® and WP Thyroid® (thyroid tablets, USP) are composed of liothyronine and levothyroxine and are used to treat underactive thyroid. The manufacturer is instructing patients who are currently taking Nature-Throid and WP Thyroid not to discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.

Consumers with questions about the recall can email RLC Labs at recall@rlclabs.com  or contact RLC Labs’ Customer Service at 1-877-797-7997, Monday through Thursday from 7:00 AM to 4:00 PM MST and Friday from 7:00 AM to 3:00 PM MST. To identify recalled product, the NDCs, product descriptions, lot numbers, and expiration dates are listed in the document found .

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

RLC Labs Issues Voluntary Nationwide Recall of All Lots of Nature-Throid® and WP Thyroid® Due to Sub Potency

FDA Publish Date: 9/3/2020

RLC Labs is voluntarily recalling a total of 483 lots of Nature-Throid and WP Thyroid in all strengths and all counts that are currently within expiry to the consumer level. The products are being recalled as testing of samples from 6 lots by the United States (US) Food and Drug Administration (FDA) found the samples to be sub potent. The product may have as low as 87% of the labeled amount of liothyronine (T3) or levothyroxine (T4).

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent Nature-Throid or WP Thyroid, may experience signs and symptoms of underactive thyroid which may include fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland, and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism. In elderly patients and patients with underlying cardiac disease, toxic cardiac manifestations of abnormal thyroid levels may occur. RLC Labs has not received any reports of adverse events related to this recall.

Nature-Throid® and WP Thyroid® (thyroid tablets, USP) are composed of liothyronine and levothyroxine and are used to treat hypothyroidism. The products subject to recall are packaged in 30, 60, 90, 100, and 1,000 count bottles.

To identify recalled product, the NDCs, product descriptions, lot numbers, and expiration dates are listed in the document found here. These lots were distributed nationwide in the US to RLC Labs’ direct accounts, including healthcare professionals and retail pharmacies.

RLC Labs is proactively notifying its wholesalers by email, mail, and phone to discontinue distribution of the product being recalled and is arranging for the return of all recalled products. The manufacturer is instructing patients who are currently taking Nature-Throid and WP Thyroid not to discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.

Consumers with questions about the recall can email RLC Labs at recall@rlclabs.com or contact RLC Labs’ Customer Service at 1-877-797-7997, Monday through Thursday from 7:00 AM to 4:00 PM MST and Friday from 7:00 am to 3:00 pm MST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the US Food and Drug Administration.

Link to FDA recall notification

Company Contact Information

Consumers: RLC Labs, Inc.

• recall@rlclabs.com

Product Photos

Click here for product photos.

Metformin ER 500 mg and 750 mg Tablets

Date: 08/20/2020

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Bayshore has posted a lot recall of Metformin Hydrochloride (HCl) Extended-Release (ER) Tablets, 500 mg and 750 mg.

About this Recall:

Bayshore Pharmaceuticals is voluntarily recalling one (1) lot of metformin HCl ER tablets, 500 mg, and one (1) lot of metformin HCl ER tablets, 750 mg, within expiration to the consumer level. The recall is due to N-nitroso-dimethylamine (NDMA) levels above the acceptable daily intake (ADI) limit. This product was manufactured by Beximco in June 2019, for United States (US) distribution by Bayshore.

What this means to you:

NDMA is a substance that could cause cancer based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods (such as meats, dairy products, and vegetables). The impacted metformin ER tablets can be identified by the NDC number found on the product label and the product lot number. The recalled NDC and lot numbers are listed on the FDA Recall Notification at the link below. Patients who have received impacted lots of metformin ER tablets are advised by the manufacturer to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the FDA, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their healthcare professionals.

Patients with medical-related questions, who wish to report an adverse event or quality issue about the products being recalled should contact Bayshore by phone at 877-372-6093.

Patients wishing to return product may contact Bayshore’s product recall processor, Qualanex, to obtain instructions and a return kit for returning their medication:

• Contact Qualanex at 888-504-2013
• Qualanex will provide the materials needed to return their medication and instructions for reimbursement

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online  or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

Bayshore Pharmaceuticals Issues Voluntary Nationwide Recall of Metformin ER Tablets 500 mg and 750 mg Due to NDMA Impurity

FDA Publish Date: 08/20/2020

Bayshore Pharmaceuticals is voluntarily recalling one (1) lot of Metformin Hydrochloride (HCl) Extended-Release (ER) Tablets USP, 500 mg, in 1000-count bottles and one (1) lot of Metformin HCl ER Tablets USP, 750 mg, in 100-count bottles within expiry to the consumer level due to the detection of N-Nitrosodimethylamine (NDMA) levels above the acceptable daily intake (ADI) Limit. This product was manufactured by Beximco in June 2019, for United States (US) distribution by Bayshore.

Bayshore was notified by the US Food and Drug Administration (FDA) that 1 lot (lot #18657) of metformin HCl ER tablets, 750 mg, was tested and showed NDMA levels in excess of the ADI limit and recommended recall of the 1 tested lot.

Bayshore has agreed to recall this lot, and out of an abundance of caution, the company has tested samples from 8 lots of metformin HCl ER tablets manufactured using same active pharmaceutical ingredient (API) lot of the failed lot. Out of 8 lots, 1 lot (lot #18657) of metformin HCl ER tablets, 750 mg, and 1 lot (lot #18641) of metformin HCl ER tablets, 500 mg, have showed NDMA levels in excess of the ADI limit. As a result, Bayshore has decided to recall the 2 lots. To date, neither Bayshore nor Beximco have received any reports of adverse events related to use of the product.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods (such as meats, dairy products, and vegetables).

Metformin HCl ER tablets USP, 500 mg and 750 mg, are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Patients who have received impacted lots of metformin ER tablets are advised by the manufacturer to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the FDA, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their healthcare professionals. Please visit the agency’s website for more information

The metformin HCl ER tablets, 500 mg and 750 mg, lots subject to the recall are identified in the table below.

The impacted metformin HCl ER tablet lots were distributed nationwide in the US by Bayshore directly to wholesalers and distributors. Bayshore is in the process of notifying its customers impacted by this recall by phone and through recall notification and is arranging for return of the recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.

Customers and patients with medical-related questions, who wish to report an adverse event or quality issue about the products being recalled should contact Bayshore by phone at 877-372-6093.

Patients wishing to return product may contact Bayshore’s product recall processor, Qualanex, to obtain instructions and a return kit for returning their medication:

• Contact Qualanex at 888-504-2013
• Qualanex will provide the materials needed to return their medication and instructions for reimbursement

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Patient safety and product quality are critical to Bayshore. Bayshore will continue to partner with, and regularly update, all relevant regulatory authorities as relevant information becomes available.

Company Contact Information

Consumers: Qualanex, Bayshore Pharmaceuticals LLC Information

• 888-504-2013
• 877-372-6093

Product Photos

For Product photos please refer to the FDA Link.

Recall of Desmopressin Nasal Sprays by Ferring Pharmaceuticals

Date: 08/05/2020

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Ferring Pharmaceuticals has posted a market recall of DDAVP® Nasal Spray 10 mcg/0.1 mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, and Stimate® Nasal Spray 1.5 mg/mL.

About this Recall:

Ferring Pharmaceuticals US is voluntarily recalling all lots on the market of DDAVP nasal spray 10 mcg/0.1mL, desmopressin acetate nasal spray 10 mcg/0.1mL, and Stimate® nasal spray 1.5 mg/mL. These products are being recalled due to amounts of desmopressin higher than specified. These results were obtained during routine testing.

What this means to you:

The risks associated with higher than specified amounts of desmopressin are due to abnormally low levels of sodium in the blood (e.g., hyponatremia) which could eventually lead to seizure, coma, and death. To date, Ferring has not received an increase in adverse event reports due to increased concentrations of desmopressin from users of the nasal spray. However, a single non-fatal adverse event potentially associated with this issue was reported during the timeframe that the impacted product was distributed.

DDAVP nasal spray and desmopressin nasal spray are both indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus as well as for the management of temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Stimate nasal spray is indicated for the treatment of patients with hemophilia A with Factor VIII coagulant activity levels greater than 5% and for the treatment of patients with mild to moderate classic von Willebrand’s disease (Type I) with Factor VIII levels greater than 5%.

The impacted product names, including the batch numbers and expiration dates, are available on the FDA Recall Notification, listed at the link on the following page. Patients and consumers can contact their physician or healthcare provider with any questions related to this recall.

 For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

Ferring Issues Voluntary Nationwide Recall of DDAVP® Nasal Spray 10 mcg/0.1 mL, Desmopressin Nasal Spray 10 mcg/0.1 mL, Stimate® Nasal Spray 1.5 mg/mL Due to Superpotency

FDA Publish Date: 08/05/2020

Ferring Pharmaceuticals is voluntarily recalling all lots on the market of DDAVP® Nasal Spray 10 mcg/0.1 mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, and Stimate® Nasal Spray 1.5 mg/mL listed in the table on the following page to the consumer level. These products are being recalled due to superpotency or amounts of desmopressin higher than specified. These out of specification results were obtained during routine testing.

The risks associated with higher than specified amounts of desmopressin relate to abnormally low levels of sodium in the blood (e.g., hyponatremia) which could eventually lead to seizure, coma, and death. To date, Ferring has not received an increase in adverse event reports due to increased concentrations of desmopressin from users of the nasal spray. A single non-fatal adverse event potentially associated with this issue was reported in the US during the timeframe that the affected product was distributed.

DDAVP nasal spray and desmopressin nasal spray are both indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus as well as for the management of temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Stimate nasal spray is indicated for the treatment of patients with hemophilia A with Factor VIII coagulant activity levels greater than 5% and for the treatment of patients with mild to moderate classic von Willebrand’s disease (Type I) with Factor VIII levels greater than 5%.

Ferring is notifying its distributors and wholesale customers by letter and asking them to check for impacted product and to return unused product through directions provided in the recall letter. The affected product name, including the batch numbers and expiration dates are found in the table below.

Distributors/wholesalers with questions regarding the recall should call Stericycle at 1-888-228-5053.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online.
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the US Food and Drug Administration.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. In the United States, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and orthopedics. For more information, call 1-888-FERRING (1-888-337-7464); visit www.FerringUSA.com.

Link to FDA recall notification

Company Contact Information

Consumers:

• 1-888-337-7464

Media: Patrick Gorman

• (862) 286-5035
• patrick.gorman@ferring.com

Product Photos

• Click here for product photos.

Recall of Metformin ER Tablets, 500 mg and 1,000 mg, by Lupin Pharmaceuticals

Date: 7/8/2020

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Lupin Pharmaceuticals has posted a market recall of metformin extended-release (ER) tablets, 500 mg and 1,000 mg.

About this Recall:

Lupin Pharmaceuticals is voluntarily recalling all batches of Metformin ER Tablets, 500 mg and 1,000 mg to the consumer level. As part of the ongoing evaluation and communication with the Food & Drug Administration (FDA), additional testing showed that certain tested batches were above the acceptable daily intake (ADI) limit for the impurity N-Nitrosodimethylamine (NDMA). Out of an abundance of caution, the company is recalling all batches of metformin ER tablets in the strengths of 500 mg and 1,000 mg in the United States (US).

What this means to you:

NDMA is a substance that could cause cancer based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods (including meats, dairy products, and vegetables). Metformin ER tablets are a prescription oral medication used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. The recalled NDCs are available at the FDA Recall Notification link found in the box on the following page.

Patients taking recalled metformin ER tablets, 500 mg or 1,000 mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the US FDA, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their healthcare providers. Please visit the agency’s website for more information.

Consumers with questions regarding this recall should contact Inmar Rx Solutions at (855) 532-1856 Monday through Friday 9:00 AM to 5:00 PM EST. For reimbursement, please have the recalled NDCs returned to Inmar Rx Solutions; the NDC number can be found on the top of the bottle label.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online 
or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

Lupin Pharmaceuticals Issues Voluntarily Nationwide Recall of Metformin ER Tablets, 500 mg and 1,000 mg Due to the Detection of NDMA Impurity

FDA Publish Date: 7/8/2020

Lupin Pharmaceuticals is voluntarily recalling all batches of Metformin Hydrochloride (HCl) Extended-Release (ER) Tablets USP, 500 mg and 1000 mg to the consumer level. As part of the ongoing assessment and continuation of dialog with the Food & Drug Administration (FDA), additional analysis revealed that certain tested batches were above the acceptable daily intake (ADI) limit for the impurity N-Nitrosodimethylamine (NDMA). Out of an abundance of caution, the company is recalling all batches of Metformin HCl ER Tablets USP, 500 mg and 1,000 mg in the United States (US). To date, Lupin Pharmaceuticals has not received any reports of adverse events related to this recall.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods, including meats, dairy products, and vegetables.

Metformin ER is a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Metformin ER tablets 500 mg and 1,000 mg are packaged in 60, 90, and 100 count bottles and were distributed nationwide in the US to wholesalers, distributors, drug chain pharmacies, mail order pharmacies, and supermarkets. The recalled NDCs are included in the table below:

Lupin Pharmaceuticals is notifying its wholesalers, distributors, drug chain pharmacies, mail order pharmacies, and supermarket customers by phone and through recall notification and is arranging for the return of all the recalled product NDCs.

Patients taking Metformin HCl ER Tablets, USP 500 mg or 1,000 mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the US FDA, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their healthcare professionals. Please visit the agency’s website for more information at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin.

Wholesalers, distributors, and retailers that have Metformin HCl ER Tablets USP, 500 mg and 1,000 mg that are being recalled should discontinue distribution of the recalled product NDCs immediately and return it to Inmar Rx Solutions, 635 Vine St., Winston Salem, NC 27101 (phone 855-532-1856).

Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (855) 532-1856 Monday through Friday 9:00 AM to 5:00 PM EST. For reimbursement, please have the recalled NDCs returned to Inmar Rx Solutions; the NDC number can be found on the top of the bottle label.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online

• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the US FDA.

Link to FDA recall notification

Company Contact Information

Consumers: Inmar, Rx Solutions, Inc.

• (855) 532-1856

Media: Arvind Bothra

• arvindbothra@lupin.com

Product Photos

Click here for product photos.

FDA Recall of Metformin ER Tablets, 750 mg by Granules Pharmaceuticals

Date: 7/6/2020

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Granules Pharmaceuticals has posted a lot recall of metformin extended-release (ER) tablets, 750 mg.

About this recall:

Granules Pharmaceuticals is voluntarily recalling twelve (12) lots of Metformin ER Tablets, 750 mg, supplied in 100 and 500 count bottles within expiration to the consumer level due to the detection of N-Nitrosodimethylamine (NDMA) levels above the acceptable daily intake (ADI) limit.

Granules’ test results showed NDMA levels above the FDA’s acceptable limit in one (1) out of the twelve (12) batches distributed in the United States (US). All other batches continue to remain within the required limits. Out of abundance of caution, Granules Pharmaceuticals has decided to voluntarily recall all twelve (12) of the distributed lots within expiration of metformin ER tablets, 750 mg.

Granules’ metformin immediate-release (IR) tablets in the strengths of 500 mg, 850 mg, and 1,000 mg as well as their metformin ER tablets in the 500 mg strength are not impacted by this recall.

What this means to you:

NDMA is a substance that could cause cancer based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods (including meats, dairy products, and vegetables).

Metformin ER tablets, 750 mg, are used as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Details for identifying the recalled lots are available at the FDA Recall Notification link found on the following page.

Patients with questions regarding this recall or wishing to return product may contact Inmar Pharmaceutical Services recall processor for instructions and a return kit for returning their medication:

• Contact Inmar at 888-985-9117 (hours of operation: 9 AM to 5 PM Eastern Time, Monday through Friday) or email Inmar at: rxrecalls@inmar.com
• Inmar will provide the materials needed to return medication and instructions for reimbursement

If you would like to report any adverse reactions or quality problems experienced with the use of this product you may contact Granules Drug Safety by phone at 1-877-770-3183 Monday through Friday, 8:00 AM to 8:00 PM EST, or via email at drugs.safety@granulesindia.com.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

Granules Pharmaceuticals Issues Voluntary Nationwide Recall of Metformin ER Tablets USP, 750 mg Due to the Detection of NDMA Impurity

FDA Publish Date: 07/06/2020

Granules Pharmaceuticals, Inc., is voluntarily recalling twelve (12) lots of Metformin Hydrochloride (HCl) Extended-Release (ER) Tablets USP, 750 mg, 100 and 500 count bottles within expiry to the consumer level due to the detection of N-Nitrosodimethylamine (NDMA) levels above the acceptable daily intake limit.

Granules’ test results showed NDMA levels above the FDA’s acceptable limit in one (1) out of the twelve (12) batches distributed to the United States (US) market. All other batches continue to remain within the specifications. Out of abundance of caution, Granules Pharmaceuticals has decided to voluntarily recall all twelve (12) of the distributed lots within expiry of Metformin HCl ER Tablets USP, 750 mg from the market.

Granules Pharmaceuticals, Inc. has not received any reports of adverse events that have been confirmed to be directly related to this recall as of the date of this letter.

Granules’ Metformin HCl Immediate-Release (IR) Tablets USP, 500 mg, 850 mg, & 1,000 mg and Metformin HCl ER Tablets USP, 500 mg are not affected by this recall.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Metformin HCl ER Tablets USP, 750 mg are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. The metformin ER tablets, 750 mg, lots subject to the recall are identified in the table on the following page.

Metformin HCl ER Tablets USP, 750 mg

The affected metformin ER tablets, 750 mg, lots were distributed nationwide in the US directly to distributors and retailers. Granules Pharmaceuticals is in the process of notifying its distributers and customers affected by this recall via mail (FedEx standard overnight) by mailing a recall notification letter and is arranging for return of the entire recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.

Customers and patients with questions regarding this recall or wishing to return product may contact Inmar Pharmaceutical Services product recall processor to obtain instructions and a return kit for returning their medication:

• Contact Inmar at 888-985-9117 (hours of operation: 9 AM to 5 PM Eastern Time, Monday through Friday) or email Inmar at: rxrecalls@inmar.com

• Inmar will provide the materials needed to return their medication and instructions for reimbursement

If you would like to report any adverse reactions or quality problems experienced with the use of this product you may contact Granules Drug Safety by phone at 1-877-770-3183 Monday through Friday, 8:00 AM to 8:00 PM EST, or via email at drugs.safety@granulesindia.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the US Food and Drug Administration (FDA).

Link to FDA Recall Notification

Company Contact Information

Consumers: Inmar, Pharmaceutical Services

• 888-985-9117
• rxrecalls@inmar.com

Media: Mary D Villalona, Director, Quality

• 571-665-2914
• mary.villalona@granulespharma.com

Product Photos

Click here to view product photos.

Children’s Robitussin® Honey Cough and Chest Congestion DM and Children’s Dimetapp® Cold and Cough Recall

Date: 06/18/2020

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

GSK Consumer Healthcare has posted a lot recall of Children’s Robitussin® Honey Cough and Chest Congestion DM and Children’s Dimetapp® Cold and Cough.

About this Recall:

GSK Consumer Healthcare is voluntarily recalling to the retail level two (2) lots of Children’s Robitussin® Honey Cough and Chest Congestion DM and one (1) lot of Children’s Dimetapp® Cold and Cough (listed at the FDA Recall Notification link below), as the packages contain incorrect dosing cups. During the review of the packaging for these products, GSK discovered that the dosing cups for the Children’s Robitussin® Honey product are missing the 5 mL and 10 mL graduations, and the dosing cups for the Children’s Dimetapp® product are missing the 10 mL graduation. The dosing cups packaged with both products only have the 20 mL graduation.

What this means to you:

There is a potential risk of accidental overdose if caregivers dispensing the syrup do not notice the differences between the graduations printed on the dosing cups and the indicated amounts to be administered (as directed in the Instructions for Use). Children’s Robitussin Honey Cough & Chest Congestion DM contains 10 mg dextromethorphan and guaifenesin 100 mg per 10 mL and is labeled for children 4 years and older and for adults. Children’s Dimetapp Cold & Cough contains 2 mg brompheniramine, 10 mg dextromethorphan, and 5 mg phenylephrine per 10 mL, and is labeled for children 6 years and older and adults. Symptoms of overdose of either product may include any of the following: impaired coordination; increase or decrease in energy; elevation in blood pressure, heart rate, or respiration; severe dizziness or drowsiness; slow heart rate; fainting; restlessness; seizure; decreased respiration; nausea; vomiting; constipation; diarrhea; abdominal pain; visual and hearing hallucinations; and urinary retention. As of the date of the recall, GSK had not received any adverse events related to this recall or consumer complaints about the incorrect dosing cups supplied with the product.

Consumers with questions regarding this recall or to report an adverse experience please call 1-800-762-4675, Monday through Friday, 8:00 AM – 6:00 PM EST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

GSK Consumer Healthcare Issues Voluntary Nationwide Recall of Children’s Robitussin® Honey Cough and Chest Congestion DM and Children’s Dimetapp® Cold and Cough Due to Dosing Cups Missing Some Graduation Markings

FDA Publish Date: 06/18/2020

GSK Consumer Healthcare is voluntarily recalling to the retail level two (2) lots (listed below) of Children’s Robitussin® Honey Cough and Chest Congestion DM and one (1) lot of Children’s Dimetapp® Cold and Cough, due to the inclusion of incorrect dosing cups. During the review of the packaging documents for these products, GSK discovered that the dosing cups for the Children’s Robitussin® Honey product are missing the 5 mL and 10 mL graduations, while the dosing cups for the Children’s Dimetapp® product are missing the 10 mL graduation. The dosing cups packaged with both products only have the 20 mL graduation.

There is a potential risk of accidental overdose if caregivers dispensing the syrup do not notice the discrepancies between the graduations printed on the dosing cups and the indicated amounts to be administered (as directed in the Instructions for Use). Children’s Robitussin Honey Cough & Chest Congestion DM contains 10 mg dextromethorphan HBr USP and guaifenesin USP 100 mg per 10 mL, and is labeled for children 4 and older, as well as adults. Children’s Dimetapp Cold & Cough contains 2 mg brompheniramine maleate USP, 10 mg dextromethorphan HBr USP, and 5 mg phenylephrine HCl USP per 10 mL, and is labeled for children 6 and older, as well as adults. Symptoms of overdose of either product may include any of the following: impaired coordination; brain stimulation causing increase in energy, elevation in blood pressure, heart rate, and respiration; a lack of energy and enthusiasm; severe dizziness or drowsiness; slow heart rate; fainting; psychotic behavior; restlessness; seizure; decreased respiration; nausea; vomiting; constipation; diarrhea; abdominal pain; visual and hearing hallucinations; urinary retention. As of the date of the recall announcement, GSK Consumer Healthcare has not received any adverse events related to these products or consumer complaints regarding the incorrect dosing cups supplied with the product.

The recall is limited to the three (3) lots listed below:

These lots were distributed nationwide between February 5, 2020 and June 3, 2020 within the United States (US). GSK Consumer Healthcare has notified wholesalers, distributors, and retailers to arrange for return of any recalled product. Wholesalers, distributors, and retailers with an existing inventory of the lots being recalled should stop distribution and quarantine these lots immediately. Wholesalers, distributors, and retailers that have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product from them.

Consumers with questions regarding this recall or to report an adverse experience please call 1-800-762-4675, Monday through Friday, 8:00 AM – 6:00 PM EST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the US Food and Drug Administration (FDA).

Company Contact Information

Consumers: GSK Contact Center

• 1-800-762-4675

Product Photos

For photos of this recall, please refer to the FDA link.

Metformin ER 500 mg Tablets

Date: 06/11/2020

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Lupin Pharmaceuticals has posted a recall of Metformin Extended-Release (ER) Tablets, 500 mg.

About this Recall:

Lupin Pharmaceuticals is voluntarily recalling 1 lot of Metformin ER Tablets, 500 mg, to the consumer level.

FDA testing showed that this lot had higher levels than the Acceptable Daily Intake limit for the impurity N-Nitrosodimethylamine (NDMA).

What this means to you:

NDMA is a substance that could cause cancer based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods (such as meats, dairy products, and vegetables).

The FDA Recall Notification linked below lists the recalled NDC and lot number. The product can be identified by the NDC and lot number listed on the side of the bottle label. Metformin ER tablets were distributed nationwide in the United States (US) to wholesalers, distributors, and mail order pharmacies.

Patients with recalled metformin ER tablets are advised by the manufacturer to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the US Food & Drug Administration (FDA), it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their healthcare provider.

Consumers with questions about this recall should contact Inmar Rx Solutions at (855) 532-1856, Monday through Friday, 9:00 AM to 5:00 PM EST. For reimbursement, please have the recalled lot returned to Inmar Rx Solutions; the lot number can be found on the side of the bottle.

 For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online  or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

Lupin Issues Voluntary Nationwide Recall of Metformin ER Tablets, 500 mg, Due to the Detection of NDMA

FDA Publish Date: 06/11/2020

Lupin Pharmaceuticals Inc. is voluntarily recalling Metformin Hydrochloride Extended-Release (ER) Tablets USP (generic equivalent of Fortamet®), 500 mg, lot G901203, to the consumer level. FDA analysis revealed that this lot exceeded the Acceptable Daily Intake (ADI) limit for the impurity N-Nitrosodimethylamine (NDMA). To date, Lupin has not received any reports of adverse events related to this recall.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods (such as meats, dairy products, and vegetables).

Metformin ER is a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. The product is packaged in a bottle containing 60 tablets with NDC 68180-0336-07. The impacted lot of metformin ER tablets 500 mg is listed in the below table:

Lupin is notifying these wholesalers, distributors, and mail order pharmacies by phone and through recall notification and is arranging for the return of all the recalled product. The manufacturer is advising patients taking recalled product to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the US Food & Drug Administration (FDA), it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their healthcare professionals. Please visit the agency’s website for more information.

Wholesalers, distributors, and retailers that have metformin ER 500 mg tablets which are being recalled should discontinue distribution of the recalled product lot immediately and return it to Inmar Rx Solutions, 635 Vine St., Winston Salem, NC 27101, phone (855) 532-1856.

Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (855) 532-1856 Monday through Friday 9:00 AM to 5:00 PM EST. For reimbursement, please have the recalled lot returned to Inmar Rx Solutions; the lot number can be found on the side of the bottle.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report online
• Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the US Food and Drug Administration.

Company Contact Information

Consumers: Inmar Rx Solutions, Inc.

• (855) 532-1856

Media: Arvind Bothrar

• +91-22-66402137
• arvindbothra@lupin.com

Product Photos

For product photos, please refer to the FDA Link.

Metformin ER 500 mg Tablets

Date: 06/05/2020

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Marksans Pharma Limited has posted a recall of Metformin Hydrochloride Extended-Release (ER) Tablets, 500 mg.

About this Recall:

Marksans Pharma Limited is voluntarily recalling one (1) lot of Metformin ER Tablets, 500 mg, to the consumer level.

The FDA has found the product contains N-Nitrosodimethylamine (NDMA) levels in excess of the acceptable daily intake (ADI) limit of 96 ng per day.

What this means to you:

NDMA is a substance that could cause cancer based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods (such as meats, dairy products, and vegetables).

The impacted metformin ER tablets can be identified by the NDC number and lot number found on the product label. The recalled NDC number, lot number, and product description are listed on the FDA Recall Notification at the link below. The FDA has stated patients should continue taking metformin tablets, even after recalls occur, until they speak with their healthcare provider who can prescribe a replacement.

Consumers with questions regarding this recall and return can contact Irene McGregor, Vice President of Regulatory Affairs for Time-Cap Labs, by phone at 1-631-753-9090, ext. 160, Monday through Friday 8 AM to 5 PM EST or by e-mail at imcgregor@timecaplabs.com.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online  or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

Marksans Pharma Limited Issues Voluntary Nationwide Recall of Metformin ER Tablets, 500 mg, Due to the Detection of NDMA

FDA Publish Date: 06/05/2020

Marksans Pharma Limited, India is voluntarily recalling Metformin Hydrochloride Extended-Release (ER) Tablets, USP 500 mg, lot # XP9004, to the consumer level. FDA analysis has found the product contains N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake (ADI) limit of 96 ng/day.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant found in water and foods, including meats, dairy products, and vegetables. Marksans Pharma has not received any reports of adverse events related to this recall to date.

Metformin Hydrochloride ER Tablets, USP 500 mg is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. The product is packaged in 100-count bottles with NDC 49483-0623-01. The affected Metformin ER Tablets, USP 500 mg, are white to off white, capsule shaped, biconvex tablets, debossed with ‘101’ on one side and plain on the other side.

Product name: Metformin Hydrochloride Extended Release Tablets USP, 500 mg

Lot #: XP9004

Expiration Date (MM/YYYY): 12/2020

The product can be identified by lot # XP9004 and expiration date 12/2020. Metformin ER Tablets, USP 500 mg, lot # XP9004 was distributed by Time-Cap Labs, Inc. (located at 7 Michael Avenue, Farmingdale, New York 11735) nationwide in the United States (US) to wholesalers who further distributed to pharmacies.

Marksans Pharma Limited is notifying its distributors and customers by issuing a notification letter and press release and is arranging for return/replacement of the recalled product lot.

Metformin Hydrochloride ER Tablets, USP 500 mg, lot # XP9004 which is being recalled should return to the place of purchase.

Consumers with questions regarding this recall and return can contact Ms. Irene McGregor (Vice President, Regulatory Affairs) of Time-Cap Labs, Inc., located at 7 Michael Avenue, Farmingdale, New York 11735, by phone number 1-631-753-9090, ext. 160, Monday through Friday 8 AM to 5 PM EST or by e-mailing imcgregor@timecaplabs.com.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 or call Time-Cap Labs, Inc. at 1-877-376-4271 or Fax at 631-753-2220

This recall is being conducted with the knowledge of the US Food and Drug Administration (FDA).

Company Contact Information

Consumers: Ms. Irene McGregor (Vice President, Regulatory Affairs) of Time-Cap Labs, Inc.

• 631-753-9090, ext. 160
• imcgregor@timecaplabs.com

Media: Dr. Meena Rani, (US Regulatory Agent and Corporate Vice President, Regulatory Affairs & Compliance)

• 631-833-9341
• usagent@marksanspharma.com

Product Photos

For Product photos please refer to the FDA Link.

Metformin ER 500 mg Tablets

Date: 06/01/2020

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Amneal has posted a recall of Metformin Hydrochloride Extended-Release (ER) Tablets, 500 mg and 750 mg.

About this Recall:

Amneal Pharmaceuticals is voluntarily recalling all lots of Metformin ER Tablets, 500 mg and 750 mg, within expiry to the retail level.

Amneal was notified by the United States (US) Food and Drug Administration (FDA) that the agency’s testing of seven lots of Metformin ER Tablets, 500 mg and 750 mg, showed N-Nitrosodimethylamine (NDMA) amounts above acceptable FDA levels. FDA recommended the recall of the seven tested lots. Amneal has agreed to this recall and has further decided to extend the recall to all lots within expiry of Metformin Hydrochloride ER Tablets, 500 mg and 750 mg, to be extra careful.

What this means to you:

NDMA is a substance that could cause cancer based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods (such as meats, dairy products, and vegetables). The impacted metformin ER tablets can be identified by the NDC number found on the product label. The recalled NDC number is listed on the FDA Recall Notification at the link below. The FDA has stated patients should continue taking metformin tablets, even after recalls occur, until they speak with their healthcare provider who can prescribe a replacement.

Amneal is notifying its direct customers via mail (UPS Standard Overnight) by mailing a recall notification letter and is arranging for return of all the recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.

Customers who purchased the impacted product directly from Amneal may call Amneal at 1-833-582-0812 or email to AmnealproductrecallDS@amneal.com, Monday – Friday, 8:00 am – 5:00 pm, EST, for further information.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

Amneal Pharmaceuticals LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, Due to the Detection of NDMA

FDA Publish Date: 06/01/2020

Amneal Pharmaceuticals LLC Bridgewater, New Jersey (Amneal), is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, within expiry to the Retail Level.

Amneal was notified by the U.S. FDA that the Agency’s testing of seven lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, showed N-Nitrosodimethylamine (NDMA) amounts above acceptable FDA levels. FDA recommended the recall of the seven tested lots. Amneal has agreed to this recall and has further decided to extend the recall to all lots within expiry of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, out of an abundance of caution. Further scientific evaluations are ongoing at Amneal.

To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall.

Amneal’s Metformin Hydrochloride Immediate Release Tablets, USP are not affected by this recall.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant found in water and foods, including meats, dairy products and vegetables.

Metformin HCl Extended Release Tablets, USP, 500 mg and 750 mg, manufactured by Amneal, are prescription, solid oral products that are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

The Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, subject to the recall, are identified by the NDC numbers stated on the product label.

Metformin HCl Extended Release Tablets, USP, 500 mg

Metformin HCl Extended Release Tablets, USP, 750 mg

The affected Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, lots were distributed nationwide in the US directly to Wholesalers, Distributors, Retailers and Repackagers.

Amneal is notifying its direct customers via mail (UPS Standard Overnight) by mailing a recall notification letter and is arranging for return of all the recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.

Customers who purchased the impacted product directly from Amneal may call Amneal at 1-833-582-0812 or email to AmnealproductrecallDS@amneal.com, Monday – Friday, 8:00 am – 5:00 pm, EST, for further information.

Retailers who have Metformin Hydrochloride Extended Release Tablets, USP, 500 mg or 750 mg, which are being recalled, should cease dispensing and contact Inmar at 855-532-1851 or via email at Rxcalls@inmar.com Monday – Friday, 8:00 am – 5:00 pm, EST, to arrange for product return.

If you would like to report any adverse reactions or quality problems experienced with the use of this product you may contact Amneal Drug Safety by phone at 1-877-835-5472, Monday – Friday, 8:00 am – 6:00 pm, EST, or via e-mail at DrugSafety@amneal.com.

Any adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company Contact Information

Consumers:

Amneal

1-833-582-0812

AmnealproductrecallDS@amneal.com

Media:

Candis Edwards

Information@amneal.com

Product Photos

For product photos please refer to the FDA Link

Metformin ER 500 mg Tablets

Date: 05/28/2020

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Apotex has posted a recall of Metformin Hydrochloride Extended-Release (ER) Tablets, 500 mg.

About this Recall:

Apotex is voluntarily recalling all lots of Metformin Hydrochloride (HCl) ER Tablets, 500 mg within expiration to the retail level. The United States (US) Food and Drug Administration (FDA) tested 1 lot of Apotex’s metformin HCl ER tablets, and found that tablets contain levels of the N-Nitrosodimethylamine (NDMA) impurity greater than the acceptable daily intake limit. As a result, the FDA recommended recall of the 1 tested lot. Apotex is recalling this lot, and out of an abundance of caution, the company has extended the recall to include all lots of Apotex’s metformin ER tablets in the US. Selling of this product was stopped in the US in February 2019 and only limited product remains on the market. To date, there have not been any reports of adverse events related to use of this product.

What this means to you:

NDMA is a substance that could cause cancer based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods (such as meats, dairy products, and vegetables). The impacted metformin ER tablets can be identified by the NDC number found on the product label. The recalled NDC number is listed on the FDA Recall Notification at the link below. The FDA has stated patients should continue taking metformin tablets, even after recalls occur, until they speak with their healthcare provider who can prescribe a replacement.

Consumers with questions regarding this recall can contact Apotex by phone at 1-800-706-5575 (8:30 AM – 5:00 PM, EST Monday through Friday) or email UScustomerservice@Apotex.com. Consumers should contact their physician or health-care provider if they have experienced any problems that may be related to taking or using this drug product.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

Apotex Issues Voluntary Nationwide Recall of Metformin ER Tablets, 500 mg Due to the Detection of NDMA

FDA Publish Date: 05/28/2020

Apotex Corp. is voluntarily recalling all lots of Metformin Hydrochloride (HCl) ER Tablets, USP 500 mg within expiration to the retail level. The United States (US) Food and Drug Administration (FDA) tested 1 lot of Apotex’s metformin HCl ER tablets, and it was found to contain levels of the N-Nitrosodimethylamine (NDMA) impurity greater than the acceptable daily intake limit. As a result, the FDA recommended recall of the 1 tested lot. Apotex is recalling this lot, and out of an abundance of caution, the company has extended the recall to include all lots of Apotex’s metformin HCl ER tablets in the US. Selling of this product was stopped in the US in February 2019 and only limited product remains on the market. To date, no reports of adverse events related to use of this product have been received.

Risk Statement: NDMA is classified as a substance that could cause cancer based on results from laboratory tests. NDMA is a known environmental contaminant and is found in water and foods (such as meats, dairy products, and vegetables). The FDA has stated patients should continue taking metformin tablets, even after recalls occur, until they speak with their health care provider who can prescribe a replacement.

The impacted metformin ER tablets were distributed nationwide in the US to warehouse chains. Apotex is in the process of notifying its affected direct account wholesaler, distributor, chain distribution, and warehousing chains via mail (FedEx Standard Overnight) by mailing a recall notification letter and is arranging for return of all recalled product.

Wholesalers, distributors and retailers should return the recalled product to the place of purchase. Anyone with an existing inventory of the product should quarantine the recalled lots immediately. Customers who purchased the impacted product directly from Apotex can call Inmar Rx Solutions at 1-888-985-9014 (option 1) (9:00 AM – 5:00 PM, EST Monday through Friday), to arrange for their return.

2—0528-2020 Class 2 Metformin ER 500 mg – Apotex Corp, Voluntary Nationwide Recall

Consumers with questions regarding this recall can contact Apotex by phone at 1-800-706-5575 (8:30 AM – 5:00 PM, EST Monday through Friday) or email UScustomerservice@Apotex.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the US Food and Drug Administration (FDA).

Company Contact Information

Consumers:

• Apotex Corp.
• 1-800-706-5575
• UScustomerservice@Apotex.com

Media:

• Jordan Berman
• 1 (416) 749-9026 Ext. 7487
• jberman@apotex.com

Product photos

NP Thyroid® (Thyroid Tablets, USP)

Date: 05/22/2020

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Acella Pharmaceuticals, LLC has posted a lot recall of NP Thyroid® (Thyroid Tablets, USP) 30 mg, 60 mg, and 90 mg.

About this Recall:

Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30 mg, 60 mg, and 90 mg NP Thyroid® (thyroid tablets, USP) to the consumer level. The products are being recalled because our testing has found these lots to be superpotent. The product may have up to 115% of the labeled amount of liothyronine (T3).

What this means to you:

Patients being treated for hypothyroidism (underactive thyroid), who receive superpotent NP Thyroid, may experience signs and symptoms of hyperthyroidism (overactive thyroid) which include, but are not limited to, weight loss, heat intolerance, fatigue, muscle weakness, high blood pressure, chest pain, rapid heart rate, or heart rhythm disturbances. Pregnant women who take superpotent NP Thyroid may also experience negative maternal and fetal outcomes including miscarriage and/or impairment of fetal development. The FDA is recommending patients who are currently taking NP Thyroid from a lot being recalled should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription. View the FDA Recall Notification at the link below for a listing of lots being recalled.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Super Potency

FDA Publish Date: 05/22/2020

Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30 mg, 60 mg, and 90 mg NP Thyroid® (thyroid tablets, USP) to the consumer level. The products are being recalled because testing has found these lots to be superpotent. The product may have up to 115% of the labeled amount of Liothyronine (T3).

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive superpotent NP Thyroid, may experience signs and symptoms of hyperthyroidism (overactive thyroid) which include, but are not limited to, weight loss, heat intolerance, fatigue, muscle weakness, hypertension (high blood pressure), chest pain, rapid heart rate, or heart rhythm disturbances. Pregnant women who take superpotent NP Thyroid may also experience negative maternal and fetal outcomes including miscarriage and/or impairment of fetal development. The FDA is recommending patients talk to their healthcare professional before they stop taking their NP Thyroid medicine. To date, Acella has received 2 reports of adverse events known to be related to this recall.

NP Thyroid (thyroid tablets, USP) is composed of levothyroxine and liothyronine, and used to treat hypothyroidism (underactive thyroid). The products subject to recall are packed in 100-count bottles. Product images are provided below.

To best identify the product, the NDCs, product description, lot numbers, and expiration dates are listed. These lots were distributed nationwide in the United States (US) to Acella’s direct accounts.

Acella is proactively notifying its wholesalers by email and phone to discontinue distribution of the product being recalled and is arranging for return of all recalled products. Patients who are currently taking NP Thyroid from the lots being recalled should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.

Consumers with questions about the recall can email Acella Pharmaceuticals at recall@acellapharma.com or contact Acella Customer Service at 1-800-541-4802, Monday through Thursday from 9:00 am to 5:00 pm ET and Friday from 9:00 am to 12:30 pm ET. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report online
• Regular Mail or Fax: download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the US Food and Drug Administration (FDA).

Company Contact Information

Consumers:

• Allen Fields, Senior Vice President, Clinical and Regulatory Affairs
• 1-800-541-4802

Product Photos:

True Metrix® Air Blood Glucose Meter

Date: 4/21/2020

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Trividia Health, Inc. has posted a recall of one (1) True Metrix® Air Blood Glucose Meter with serial number TA1548753. The recalled meter was packaged into a True Metrix Blood Glucose Meter Kit with the lot number and UDI number shown below, and this kit was distributed nationwide in the United States in February 2019.

About this Recall:

Trividia Health, Inc. has announced a nationwide voluntary recall of one (1) True Metrix® Air Blood Glucose Meter distributed in the United States to AssuraMed. The one (1) impacted meter was packaged into a True Metrix Blood Glucose Meter Kit with the Lot number KW0135 and with UDI number (01)00021292006075(17) 200831(10)KW0135(21)TA1548753.

What this means to you:

The recalled meter has an incorrect factory-set unit of measure and displays blood glucose results in mmol/L rather than mg/dL. If this incorrect unit of measure is not noticed, the potential exists for the meter glucose result to be read as a lower blood glucose reading than expected. This can lead to the patient’s glucose level remaining high, which could result in serious injury or lead to life-threatening complications.

Consumers who have or may have the recalled True Metrix Air meter are instructed by the manufacturer to do the following:

• Check to confirm if you have the impacted True Metrix Air meter by obtaining the meter serial number (TA1548753) from the serial number label located on the back of the meter, and then visit www.TrividiaHealth.com/air-product-notice or call Trividia Health toll-free at 1-800-518-5726, Monday to Friday, 8 AM to 8 PM EST.
• If you have the impacted True Metrix Air meter, please stop using the meter and call Trividia Health immediately to verify the serial number, and to expedite return and replacement of the recalled True Metrix Air meter at no charge.
• Consumers may continue to test blood glucose using any other Trividia Health blood glucose meter not included in this voluntary recall while waiting for their replacement meter to arrive. Use only the test strips that are intended for use with your blood glucose meter.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

Trividia Health, Inc. Issues Nationwide Voluntary Recall for an Isolated True Metrix® Air Blood Glucose Meter with Serial Number TA1548753

FDA Publish Date: 4/21/2020

Trividia Health, Inc. today announced it is initiating a nationwide voluntary recall of one (1) True Metrix® Air Blood Glucose Meter distributed in the United States to one customer (AssuraMed). The meter was not packaged into store-brand or retail branded packaging.

The company has determined that one (1) isolated True Metrix Air Blood Glucose Meter was packaged into a True Metrix Blood Glucose Meter kit and has an incorrect factory-set unit of measure; the meter displays glucose results in mmol/L rather than mg/dL. If a consumer does not notice the incorrect unit of measure, it is possible that the meter glucose result will be read as a lower blood glucose result than expected, and this may result in the patient’s glucose level remaining high, which can lead to serious injury or impairment with risk of death.

There is one (1) affected True Metrix Air meter with serial number TA1548753 that was packaged into a True Metrix Blood Glucose Meter Kit with the Lot number KW0135 and with UDI number (01)00021292006075(17)200831(10)KW0135(21)TA1548753. It has been determined that this kit was distributed nationwide in the United States (US) in February 2019. Trividia Health has not received any reports of patient injury or an adverse event related to this voluntary recall.

Consumers who have or may have the recalled True Metrix Air meter are instructed by the manufacturer to do the following:

• Check to confirm if you have the affected True Metrix Air meter by obtaining the meter serial number ( TA1548753) from the serial number label located on the back of the meter, and then visit www.TrividiaHealth.com/air-product-notice or call Trividia Health toll-free at 1-800-518-5726, Monday – Friday, 8 AM – 8 PM EST.

• If you have the affected True Metrix Air meter, please stop using the meter and call Trividia Health immediately to verify the serial number, and to expedite return and replacement of the affected True Metrix Air meter at no charge.

Consumers may continue to test blood glucose using any other Trividia Health blood glucose meter not included in this voluntary recall while waiting for their replacement meter to arrive. Use only the test strips that are intended for use with your blood glucose meter.

Notifications will be sent to US pharmacies, durable medical equipment providers and distributors who may have received this device from Trividia’s customer.

Patient safety is a top priority at Trividia Health. The company has notified the US Food and Drug Administration (FDA) of this voluntary product recall and is working with the customer who received the affected meter to quickly resolve this matter.

Users within the US may report adverse reactions or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online or by phone.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the US FDA.

Company Contact Information

Consumers: Trividia Health

• 1-800-518-5726

Media: Annmarie Ramos, Sr. Manager, Product Marketing

• 800-342-7226, ext. 3190

Tetracycline HCl Capsules 250 mg and 500 mg

Date: 4/16/2020

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Avet Pharmaceuticals has posted a lot recall of Tetracycline HCl capsules.

About this Recall:

Avet Pharmaceuticals Inc. is initiating a voluntary recall of 8 lots of Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles to the consumer/user level. A list of impacted lots is available at the FDA Recall Notification website below.

What this means to you:

Avet is notifying its distributors and customers and is arranging for the return of all recalled products. Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking this drug product.

Consumers with questions regarding this recall should contact Qualanex at 1-888-424-4341 Monday – Friday, 8:00 am – 5:00 pm, EST or via email at recall@qualanex.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

Avet Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Tetracycline HCl Capsules USP, 250 mg and 500 mg Due to Failed Dissolution Specifications

FDA Publish Date: 4/16/2020

Avet Pharmaceuticals Inc. (“Avet”), based in East Brunswick, New Jersey, is initiating a voluntary recall of the following lots of Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles listed in the table below to the consumer/user level.

These drug products are manufactured by Avet Pharmaceuticals and distributed under the Heritage Pharmaceuticals label. The voluntary recall is being initiated due to low out of specification dissolution test results.

Low dissolution results in less tetracycline available in the body to fight infection. This can lead to treatment failures. For patients with compromised immune systems and the elderly, who may be taking tetracycline to treat a serious infection such as pneumonia, there is a reasonable probability that if there is not enough tetracycline in

2—0415-2020 Class 1 Tetracycline HCl Capsules – Avet Pharmaceuticals Voluntary Nationwide Recall

the body to fight the infection, this could result in rapid progression of the infection and death. To date, Avet has not received adverse event reports or complaints related to this event.

Tetracycline HCl Capsules USP, 250 mg and 500 mg are indicated in the treatment of infections caused by susceptible strains of the designated organisms, including upper and lower respiratory infections, skin and soft tissues infections, infections caused by Rickettsiae, and as an adjunctive therapy in severe acne. The recalled Tetracycline HCl Capsules 250 mg and 500 mg lots were distributed to wholesalers and distributors nationwide in the US between August 2019 and March 2020.

Avet is notifying its distributors and customers and is arranging for the return of all recalled products. Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking this drug product. Pharmacies and healthcare facilities that have the drug product subject to this recall should immediately stop dispensing this drug product.

Consumers with questions regarding this recall should contact Qualanex at 1-888-424-4341, Monday – Friday, 8:00 am – 5:00 pm, EST or via email at recall@qualanex.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the US Food and Drug Administration.

Company Contact Information

Consumers: Avet Pharmaceuticals Inc.

• 1-888-424-4341
• recall@qualanex.com

Ketorolac Tromethamine Injection, USP, 30 mg/mL, and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL

Date: 4/20/2020

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Fresenius Kabi USA, LLC has posted a lot recall of Ketorolac Tromethamine Injection, USP, 30 mg/mL, and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL.

About this Recall:

Fresenius Kabi USA, LLC is voluntarily recalling 13 lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL, 2 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter. These particles were found in 8 sample vials.

What this means to you:

Customers with questions regarding this recall may contact Fresenius Kabi at 1-866-716-2459 Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Time. The FDA is directing consumers to contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2

Fresenius Kabi Issues Voluntary Nationwide Recall of 13 Lots of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter in Reserve Samples

FDA Publish Date: 4/20/2020

Fresenius Kabi USA, LLC is voluntarily recalling 13 lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter composed of the following elements: carbon, silicon, oxygen and polyamides. Particulate matter was found in eight reserve sample vials.

Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences.

Ketorolac Tromethamine, a nonsteroidal anti-inflammatory drug, is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. The total combined duration of use of oral Ketorolac Tromethamine and Ketorolac Tromethamine injection should not exceed 5 days.

Listed below is a table of the recalled lots distributed nationwide to wholesalers, distributors, hospitals, and pharmacies between May 5, 2018 and December 16, 2019, as well as a copy of the label:

Fresenius Kabi is notifying its distributors and customers by letter and asking customers and distributors to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product. Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing any affected lots, and to return the product to Fresenius Kabi. The recall letter and response form are available at https://www.fresenius-kabi.com/us/pharmaceutical-product-updates

Customers with questions regarding this recall may contact Fresenius Kabi at 1-866-716-2459 Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Time. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
• Or, contact Fresenius Kabi at 1-800-551-7176, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. or via email at: productcomplaint.USA@fresenius-kabi.com adverse.events.USA@fresenius-kabi.com or

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Tetracycline HCl Capsules 250 mg and 500 mg

Date: 4/16/2020

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Avet Pharmaceuticals has posted a lot recall of Tetracycline HCl capsules.

About this Recall:

Avet Pharmaceuticals Inc. is initiating a voluntary recall of 8 lots of Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles to the consumer/user level. A list of impacted lots is available at the FDA Recall Notification website below.

What this means to you:

Avet is notifying its distributors and customers and is arranging for the return of all recalled products. Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking this drug product.

Consumers with questions regarding this recall should contact Qualanex at 1-888-424-4341 Monday – Friday, 8:00 am – 5:00 pm, EST or via email at recall@qualanex.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

Avet Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Tetracycline HCl Capsules USP, 250 mg and 500 mg Due to Failed Dissolution Specifications

FDA Publish Date: 4/16/2020

Avet Pharmaceuticals Inc. (“Avet”), based in East Brunswick, New Jersey, is initiating a voluntary recall of the following lots of Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles listed in the table below to the consumer/user level.

These drug products are manufactured by Avet Pharmaceuticals and distributed under the Heritage Pharmaceuticals label. The voluntary recall is being initiated due to low out of specification dissolution test results.

Low dissolution results in less tetracycline available in the body to fight infection. This can lead to treatment failures. For patients with compromised immune systems and the elderly, who may be taking tetracycline to treat a serious infection such as pneumonia, there is a reasonable probability that if there is not enough tetracycline in the body to fight the infection, this could result in rapid progression of the infection and death. To date, Avet has not received adverse event reports or complaints related to this event.

Tetracycline HCl Capsules USP, 250 mg and 500 mg are indicated in the treatment of infections caused by susceptible strains of the designated organisms, including upper and lower respiratory infections, skin and soft tissues infections, infections caused by Rickettsiae, and as an adjunctive therapy in severe acne. The recalled Tetracycline HCl Capsules 250 mg and 500 mg lots were distributed to wholesalers and distributors nationwide in the US between August 2019 and March 2020.

Avet is notifying its distributors and customers and is arranging for the return of all recalled products. Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking this drug product. Pharmacies and healthcare facilities that have the drug product subject to this recall should immediately stop dispensing this drug product.

Consumers with questions regarding this recall should contact Qualanex at 1-888-424-4341, Monday – Friday, 8:00 am – 5:00 pm, EST or via email at recall@qualanex.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the US Food and Drug Administration.

Company Contact Information

Consumers: Avet Pharmaceuticals Inc.

• 1-888-424-4341
• recall@qualanex.com

Nizatidine Oral Solution 15 mg/mL

Date: 4/15/2020

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Amneal Pharmaceuticals has posted a lot recall of Nizatidine Oral Solution 15 mg/mL.

About this Recall:

Amneal Pharmaceuticals, LLC, Bridgewater, New Jersey is voluntarily recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL), packaged in 480 mL bottles to the Consumer Level. Nizatidine Oral Solution was distributed by Gemini Laboratories, LLC, a wholly owned subsidiary of Amneal Pharmaceuticals. The three recalled lots are identified in the FDA Recall Notification link below. Nizatidine Oral Solution is being recalled due to potential N-Nitrosodimethylamine (NDMA) amounts exceeding the levels established by the FDA.

What this means to you:

Customers who purchased the impacted product directly from Amneal can call Inmar at (855) 319-4807, Monday – Friday, 8:00 am – 6:00 pm, EST, or e-mail at DrugSafety@amneal.com for further information. Consumers should contact their physician or other healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Consumers who have Nizatidine Oral Solution which is being recalled should stop using the product and can call Inmar at 855-319-4807, Monday – Friday, 8:00 am – 5:00 pm, EST for further information.

Consumers who would like to report adverse reactions or quality problems experienced with the use of this product can contact Amneal Drug Safety by phone at 1-877-835-5472, Monday thru Friday, 8:00 am – 6:00 pm, EST, or e-mail at DrugSafety@amneal.com.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.

For more information regarding this FDA Recall Notification, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Nizatidine Oral Solution, 15 mg/mL, Due to Potential Levels of NDMA Impurity Amounts Above the Levels Established by FDA

FDA Publish Date: 4/15/2020

Amneal Pharmaceuticals, LLC, Bridgewater, New Jersey is voluntarily recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL), packaged in 480 mL bottles to the Consumer Level. Nizatidine Oral Solution was distributed by Gemini Laboratories, LLC, a wholly owned subsidiary of Amneal Pharmaceuticals. The three recalled lots are identified in the table below. Nizatidine Oral Solution is being recalled due to potential N-Nitrosodimethylamine (NDMA) amounts exceeding the levels established by the FDA.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Amneal Pharmaceuticals, LLC has not received any reports of adverse events that have been confirmed to be directly related to this recall. Nizatidine Oral Solution manufactured by Amneal, is a prescription oral product used for the short-term treatment and maintenance therapy of ulcers and for the treatment of esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD).

The Nizatidine Oral Solution lots subject to the recall can be identified by the NDC number and lot number listed on the product label:

The affected Nizatidine Oral Solution lots were distributed directly to wholesalers who further distributed to retail pharmacies and consumers nationwide in the USA.

Amneal is notifying its direct customers by mailing (FED Ex Standard Overnight) a recall notification letter and is arranging for return of all recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.

Customers who purchased the impacted product directly from Amneal can call Inmar at (855) 319-4807, Monday – Friday, 8:00 am – 6:00 pm, EST, or e-mail at DrugSafety@amneal.com for further information. Consumers should contact their physician or other healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Consumers who have Nizatidine Oral Solution which is being recalled should stop using the product and can call Inmar at 855-319-4807, Monday – Friday, 8:00 am – 5:00 pm, EST for further information.

Consumers who would like to report adverse reactions or quality problems experienced with the use of this product can contact Amneal Drug Safety by phone at 1-877-835-5472, Monday thru Friday, 8:00 am – 6:00 pm, EST, or e-mail at DrugSafety@amneal.com.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Link to FDA website.

Company Contact Information

Consumers: Inmar

• 855-319-4807
• DrugSafety@amneal.com

Media: Ms. Candis Edwards

• Information@amneal.com

Ranitidine Products

Date: 4/1/2020

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall and withdrawal information. The FDA has posted a full market withdrawal of ALL Ranitidine Products.

About this Withdrawal:

The U.S. Food and Drug Administration (FDA) today announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as NNitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac).

What this means to you:

Patients and consumers should contact their physician or health care provider with any questions related to this withdrawal and/or if they have experienced any problems that may be related to taking Ranitidine Products. The FDA recommends consumers stop taking OTC ranitidine drugs and consider other approved OTC products if they wish to continue treating their condition. The FDA also recommends if you have had a prescription for this drug, to talk with your doctor or pharmacist before stopping this drug. Because of the current COVID-19 pandemic, the FDA recommends consumers not take their drugs to a drug take-back location but follow the specific disposal directions in the medication guide or package insert or follow the FDA’s recommended steps, which include ways to safely dispose of these drugs at home.

For more information regarding this FDA Withdrawal Notification, please refer to the FDA website.

Complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2

FDA Requests Removal of All Ranitidine Products (Zantac) from the Market FDA

Publish Date: 04/01/2020

The U.S. Food and Drug Administration today announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.

“The FDA is committed to ensuring that the medicines Americans take are safe and effective. We make every effort to investigate potential health risks and provide our recommendations to the public based on the best available science. We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.”

NDMA is a probable human carcinogen (a substance that could cause cancer). In the summer of 2019, the FDA became aware of independent laboratory testing that found NDMA in ranitidine. Low levels of NDMA are commonly ingested in the diet, for example NDMA is present in foods and in water. These low levels would not be expected to lead to an increase in the risk of cancer. However, sustained higher levels of exposure may increase the risk of cancer in humans. The FDA conducted thorough laboratory tests and found NDMA in ranitidine at low levels. At the time, the agency did not have enough scientific evidence to recommend whether individuals should continue or stop taking ranitidine medicines, and continued its investigation and warned the public in September 2019 of the potential risks and to consider alternative OTC and prescription treatments.

New FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers. The testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.

With today’s announcement, the FDA is sending letters to all manufacturers of ranitidine requesting they withdraw their products from the market. The FDA is also advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more; for those who wish to continue treating their condition, they should consider using other approved OTC products. Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA. To date, the FDA’s testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).

In light of the current COVID-19 pandemic, the FDA recommends patients and consumers not take their medicines to a drug take-back location but follow the specific disposal instructions in the medication guide or package insert or follow the agency’s recommended steps, which include ways to safely dispose of these medications at home.

The FDA continues its ongoing review, surveillance, compliance and pharmaceutical quality efforts across every product area, and will continue to work with drug manufacturers to ensure safe, effective and high-quality drugs for the American public. The FDA encourages health care professionals and patients to report adverse reactions or quality problems with any human drugs to the agency’s MedWatch Adverse Event Reporting program:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Inquiries Media: Consumer: Sarah Peddicord

• 888-INFO-FDA
• 301-796-2805

Related Information

• Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac)
• What to Know and Do About Possible Nitrosamines in Your Medication
• Information about Nitrosamine Impurities in Medications Link to full FDA Alert: FDA Alert Ranitidine HCL Full Market Withdrawal

Link to full FDA Alert: FDA Alert Ranitidine HCL Full Market Withdrawal

Ketorolac Tromethamine Injection, 30mg/mL

FDA Publish Date: 03/05/2020

At Magellan Rx Management, we want to help you get the best possible care. We have a website to share drug recall information.

Hikma Pharmaceuticals has posted a lot recall of Ketorolac Tromethamine Injection, 30mg/mL.

About this Recall:

Hikma Pharmaceuticals is voluntarily extending its prior recall of certain lots of Ketorolac Tromethamine Injection USP 30mg/mL. The drug is being recalled because small black pieces, were seen in some of the recalled lots.

What this means to you:

Patients and consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using Ketorolac Tromethamine Injection, 30mg/mL.

For more information regarding FDA Recall Notifications, please refer to the FDA website.

FDA contact information for reporting adverse events/quality complaints can be reached online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then select prompt #2.

Hikma Pharmaceuticals USA Inc. Extends Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP 30mg/mL, 1mL Fill/2mL Vials Due to the Potential Presence of Small Particulates

FDA Publish Date: 03/05/2020

Hikma Pharmaceuticals PLC (Hikma, Group), today announces that its subsidiary Hikma Pharmaceuticals USA Inc. (formerly known as West-Ward Pharmaceuticals Corp.; “Hikma”) is voluntarily extending its previously-announced recall of certain lots (listed below) of Ketorolac Tromethamine Injection USP 30mg/mL, 1mL fill/2mL vials to the medical facility and retail levels.

The product is being recalled due to the presence of small visible particulate matters of a gelatinous/oily nature that appear black in some of the recalled lots. On December 23, 2019, Hikma voluntarily initiated a recall of this product to the direct customer level.

In coordination with the U.S. Food and Drug Administration (FDA), Hikma is extending the recall to the medical facility and retail levels. Administration of the affected product could potentially result in the deposition of particulates in the lungs of patients, which could result in multiple pulmonary microemboli with subsequent acute respiratory distress for patients receiving the drug intravenously.

Although Hikma has not received any reports of adverse events related to this issue, it is nonetheless extending its recall of these products out of an abundance of caution and to promote patient safety, which is Hikma’s highest priority.

The lots being recalled were manufactured between March 22, 2018, and February 21, 2019. Hikma investigated the cause of the problem and decided to suspend manufacturing of this product until an appropriate solution can be implemented to prevent recurrence.

Ketorolac Tromethamine Injection is a nonsteroidal anti-inflammatory drug (“NSAID”) that is indicated for the shortterm (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level.

The affected lot numbers and expiration dates being recalled are as follows:

The product can be identified by name and NDC and lot codes, which are clearly stated on the product label, along with Hikma Pharmaceuticals USA Inc./West-Ward Pharmaceutical Corp.’s name and address. Images of the vial and shelf pack labels are included below:

The product was distributed to Hikma’s direct customers nationwide. Hikma notified its direct customers as part of the initial recall, asking them to contact medical and retail level facilities to locate and remove the recalled product from distribution channels and return the recalled lots to Hikma. Hikma is now asking customers at the medical and retail level facilities to locate and remove the recalled product from their channels and return the recalled lots to Hikma.

For recall inquiries, please contact Hikma using the information provided below:

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Link to FDA website.