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Drug Recalls

10/25/2022 Octreotide Acetate Injection by Mylan Institutional LLC

Mylan Institutional Issues a Voluntary Recall of 1 Lot of Octreotide Acetate Injection, 500 mcg/mL, Due to Glass Particulates in a Syringe.


Date: 11/11/2022

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

Mylan Institutional has posted 1 lot recall of Octreotide Acetate Injection, 500 mcg/mL.

About this recall:
Mylan Institutional is voluntarily recalling lot AJ21002, exp 3/2024, of Octreotide Acetate Injection, 500 mcg/mL,
packaged in a carton of ten 1mL syringes. This lot is being recalled at the user (hospital/pharmacy) level due to a
product complaint of the presence of glass particles in a syringe.

For lot recalls, the lot/batch information and expiration date for the recalled product can be viewed by clicking on
the link to the FDA Recall Notification found below.

Octreotide Acetate Injection is indicated to reduce blood levels of growth hormone (GH) and insulin growth factor1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with
surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. It is also indicated for the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease and for the treatment of the profuse watery diarrhea associated with vasoactive intestinal peptide (VIP)-secreting tumors.

What this means to you:
Intravenous administration of a solution containing particulate matter, such as a glass, could lead to events
including, but not limited to, local irritation or swelling, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism. Although the intravenous administration of a solution containing particulate matter may pose potential risk of serious adverse events, the probability of exposure from this incident and subsequent risk is low. To date, no reports of adverse reactions associated with this lot have been received.

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.

This recall communication is from the 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.

10/25/2022 Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg by Aurobindo Pharma USA, Inc

Aurobindo Pharma USAInitiates a Voluntary Nationwide Recall of 2 Lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, Due to the Detection of NNitroso Quinapril Impurity


Date: 11/01/2022

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

Aurobindo Pharma USA has posted 2 lot recalls of Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg.

About this recall:
Aurobindo Pharma USAhas initiated a voluntary recall of 2 lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg, to the consumer level from the US market due to the presence of Nitrosamine Drug Substance
Related Impurity (NDSRI), N-Nitroso-Quinapril above the proposed interim limit. Lot #QE2021005-A and #QE2021010-A.

For lot recalls, the lot/batch information and expiration date for the recalled product can be viewed by clicking on the link to the FDA Recall Notification found below.

Quinapril and Hydrochlorothiazide Tablets, USP are fixed-combination tablets that combine an angiotensinconverting enzyme (ACE) inhibitor, quinapril hydrochloride, and a thiazide diuretic, hydrochlorothiazide. This product is indicated for the treatment of high blood pressure. Patients should contact their doctor or health care provider about whether to continue taking their medication, or whether to consider an alternative treatment prior to returning their medication.

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. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this 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 please contact Qualanex at 1-888-504- 2014 (live calls received 7:00 am to 4:00 pm M-F CST).

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.

This recall communication is from the 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.

 

09/29/2022 Atenolol 25 mg Tablets_Clopidogrel 75 mg Tablets by Golden State Medical Supply Recall Notice

Golden State Medical SupplyIssues a Voluntary Nationwide Recall of Atenolol 25
mg Tablets and Clopidogrel 75 mg Tablets Due to incorrect labeling


Date: 10/24/2022

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

Golden State Medical Supply has posted a lot recall of Atenolol 25mg Tablets and Clopidogrel 75mg Tablets.

About this recall:
Golden State Medical Supply- has initiated a voluntary recall of Clopidogrel 75 mg tablets, 1,000 count bottle and Atenolol 25 mg tablets, 1000 count bottle. A report was received that a bottle containing Clopidogrel 75mg Tablets produced with lot# GS046745 was mislabeled as Atenolol 25mg Tablets. This voluntary recall only affects products with lot# GS046745. No other Clopidogrel or Atenolol products marketed by GSMS, Inc. are impacted. Both products are being recalled out of abundance of caution.

For lot recalls, the lot/batch information and expiration date for the recalled product can be viewed by clicking on the link to the FDA Recall Notification found below.

Atenolol tablets are indicated for the treatment of high blood pressure. Clopidogrel is prescribed to lower the risk of having a stroke, blood clot, or serious heart problem for patients who have had heart attack, severe chest pain,or circulation problems as indicated in the product labeling.

What this means to you:
Patients who suddenly stop taking atenolol are at an increased risk for reduced blood flow (chest pain, heart attack), high blood pressure and abnormal heart rhythm adverse events relating to rapid withdrawal of beta antagonism. Further, patients who are on atenolol are frequently on concomitant anticoagulant and antiplatelet medications and would be at increased risk for bleeding if clopidogrel were added to the regimen.

Consumers with questions regarding this recall can contact Golden State Medical Supply by: Phone: (800) 284-8633, ext. 116 (include days between 7:30 AM to 4:00 PM, Pacific)

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.

This recall communication is from the 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.

 

08/04/2022 Magnesium Citrate Saline Laxative Oral Solution by Vi-Jon- Recall Notice

Vi-Jon Expands Voluntary Worldwide Recall of All Flavors and Lots within Expiry of Magnesium Citrate Saline Laxative Oral Solution Due to Microbial Contamination


Date: 08/04/2022

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

Vi-Jon has posted a full lot recall of Magnesium Citrate Saline Laxative Oral Solution.

About this recall:
Vi-Jon is revising a previously reported list of all flavors of Magnesium Citrate Saline Laxative Oral Solution within expiry that were voluntarily recalled to the consumer level to include product that was distributed in the United States, Canada, and Panama. This includes all lots of lemon flavor, cherry flavor, and grape flavor of Magnesium Citrate Saline Laxative Oral Solution, 296 mL within expiry. The recall was initiated after Vi-Jon’s third party microbial testing identified the presence of Gluconacetobacter liquefaciens. The initial recall for 1 lot of lemon flavor was issued in June 2022; this recall was expanded to include all lots of lemon flavor on July 15, 2022 and subsequently all lots all flavors on July 26, 2022. In August 2022, the revised listing of recalled products was issued.

The product names and NDC numbers for the recalled product can be viewed by clicking on the link to the FDA Recall Notification found below.

The product is used for relief of occasional constipation (irregularity) and generally produces a bowel movement in a ½ hour to 6 hours.

What this means to you:
Patients with weakened immune systems (immunocompromised), who consume this product, may be at increased risk for serious infections caused by Gluconacetobacter liquefaciens that could lead to life-threatening
health consequences. To date, Vi-Jon is aware of 3 reports of serious side effects potentially related to this recall. Vi-Jon is in the process of investigating these reports. Consumers with questions regarding this recall can contact Vi-Jon by e-mail (Recalls@Vijon.com) or phone call (615) 208-2441, Monday to Friday, from 7:30 am to 4:30 pm, 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.

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

This recall communication is from the 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.

 

 

07/06/2022 Insulin Glargine Injection by Mylan- Recall Notice

Mylan Pharmaceuticals Issues Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection Pens, 100 units/mL (U-100), Due to the Potential of Missing Labels


Date: 07/06/2022

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

Mylan Pharmaceuticals has posted a lot recall of insulin glargine.

About this recall:
Mylan Pharmaceuticals is voluntarily recalling 1batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens which are packaged in cartons of five pens to the consumer level. This product is not the branded Semglee® pen but the unbranded Insulin Glargine-yfgn pens, NDC 49502-394-75. This batch is being recalled due to the potential for missing labels on pens For lot recalls, the lot/batch information and expiration date for the recalled product can be viewed by clicking on the link to the FDA Recall Notification found below.

This product is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

What this means to you:
For patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), a missing label on Insulin Glargine pens could lead to a mix-up of products/strengths, which may result in either high or low blood sugar and could lead to serious complications. To date, no adverse events related to this recall have been received for this product.

If you have an unlabeled pen, please contact Sedgwick at 1-877-643-8438 for the documentation packet to return the product.

Consumers with questions regarding this recall can contact Viatris Customer Relations by phone at 1-800-796-9526 or by email at customer.service@viatris.com, Monday through Friday from 8 a.m. – 5 p.m. EST. 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.

This recall communication is from the 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.

 

06/29/2022 Morphine Sulfate by Bryant Ranch- Recall Notice

Bryant Ranch Prepack Issues Voluntary Nationwide Recall of Morphine Sulfate 30 mg Extended Release Tablets and Morphine Sulfate 60 mg Extended-Release Tablets Due to Label-Mix Up


Date: 06/29/2022

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 Morphine Sulfate 30 mg and 60 mg Extended-Release tablets.

About this recall:
Bryant Ranch Prepack. is voluntarily recalling one lot of Morphine Sulfate 30 mg Extended-Release tablets (comprised of 10 bottles), and one lot of Morphine Sulfate 60 mg Extended-Release tablets (comprised of 10 bottles) to the consumer level listed in the table below. The products have been found to have incorrect labeling. Bottles labeled Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg ExtendedRelease tablets and bottles labeled Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.

For lot recalls, the lot/batch information and expiration date for the recalled product can be viewed by clicking on
the link to the FDA Recall Notification found below.

What this means to you:
Morphine Sulfate Extended-Release tablets are used to manage severe pain. The 30 mg tablets are round, purple-colored, film-coated tablets debossed with “RD” and “71” on one side and plain on the other side. The 60 mg
2—0622-2022 Class 1 Morphine Sulfate Extended-Release tablets – Bryan Ranch Prepack Inc Voluntary Recall tablets are round, light orange-colored, film-coated tablets debossed with “RD” and “72” on one side and plain on
the other side.

Risk Statement: Patients prescribed the 30 mg dose who receive the 60 mg dose could be at risk for overdose and
death. Patients prescribed the 60 mg dose who receive the 30 mg dose may experience withdrawal and untreated
pain if the dose given is too low. To date, Bryant Ranch Prepack Inc. has not received any reports of adverse events
related to this recall.

Bryant Ranch Prepack is notifying its distributors and customers by email, phone, and letter, and is arranging for
return of all recalled products. Consumers/distributors/retailers that have these products which are being recalled
should stop using and contact Bryant Ranch Prepack Inc. at: cs@brppharma.com or call 877-885-0882.

Consumers with questions regarding this recall can contact Bryant Ranch Prepack Inc. at 877-885-0882
or cs@brppharma.com, Monday-Friday 7:30am-5:00pm PDT. 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.

This recall communication is from the 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.

 

 

06/22/2022 Magnesium Citrate Saline Laxative by Vi-Jon- Recall Notice

Vi-Jon Issues Voluntary Nationwide Recall of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination


Date: 06/22/2022

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information. Vi-Jon has posted a lot recall of Magnesium Citrate Saline Laxative Oral Solution, Lemon Flavor.

About this recall:
Vi-Jon is voluntarily recalling 1 lot of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) to the consumer level. Testing identified the affected lot of the product to contain the bacteria Gluconacetobacterliquefaciens.

For lot recalls, the lot/batch information and expiration date for the recalled product can be viewed by clicking on the link to the FDA Recall Notification found below.

The product is used for relief of occasional constipation (irregularity) and generally produces a bowel movement in 1/2 to 6 hours. The product is packaged in a 10 oz clear round plastic bottle. The affected CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor lot includes the following batch number: 0556808 and expiration date: 12/2023 on the shoulder of the bottle. This lot of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor was sent to a 3rd party outside lab for testing per CVS request as a first production sample for CVS. This lot of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor was distributed Nationwide at CVS drug store locations.

What this means to you:
Immunocompromised patients, who consume this product, may be at increased risk for invasive infections caused by Gluconacetobacter liquefaciens that could lead to serious, life threatening adverse health consequences. To date, ViJon has not received any complaints related to this recall.

Vi-Jon has already notified CVS by phone and email and is arranging for return of all recalled product.

Consumers that have this recalled product should stop using and return any remaining product to the place of purchase.

Consumers with questions regarding this recall can contact Vi-Jon by e-mail Recalls@Vijon.com Monday-Friday, from 7:30 am to 4:30 pm 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.

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

This recall communication is from the 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.

 

05/23/2022 Anagrelide by Teva- Member

Teva Pharmaceuticals USA has posted a lot recall of Anagrelide Capsules.

About this recall:
Teva Pharmaceuticals USA has initiated a voluntary nationwide recall of a single lot of Anagrelide Capsules, USP 0.5 mg (NDC 0172-5241-60), to the consumer level in the United States. This voluntary recall was initiated due to failure of the product to dissolve during routine stability testing. No other lots are impacted.

For lot recalls, the lot/batch information and expiration date for the recalled product can be viewed by clicking on the link to the FDA
Recall Notification found below.

Anagrelide capsules are indicated for the treatment of patients with high platelet counts, secondary to certain cancers, to reduce the elevated platelet count and the risk of blood clots and to prevent associated symptoms including clotting/bleeding events.

What this means to you:
If the drug does not dissolve it can lead to less anagrelide available in the body. For seriously ill patients with elevated platelet counts, less available anagrelide in the body could increase the risk of clotting (blood coagulation) and bleeding events such as a heart attack or stroke, which could be life-threatening. To date, Teva has not received any product quality complaints or adverse event reports for the recalled lot.

According to the manufacturer, as a patient, your first course of action should be to consult with your pharmacist, healthcare provider, or physician who can advise you about an alternative treatment prior to discontinuation of the medication.

The risks from stopping the medication may be higher than the potential risk of continuing anagrelide treatment for a short period of time. Once your pharmacist, healthcare provider, or physician has provided an alternate medication to treat the condition, the manufacturer requests that you return any remaining product in your possession. Please contact Teva’s product recall processor to obtain instructions and a kit for returning your medication: Inmar (866-431-5972 – Dedicated Phone Line) or email Inmar at rxrecalls@inmar.com.

Inmar will provide the materials that you will need to return your medication, which will include a pre-paid mailer and instructions for your reimbursement.

Consumers with questions or concerns should first consult with their health care provider(s). To report an Adverse Event or Quality Complaint, or if you have Medical Related Questions, please use the following contact information:

Medical-related Questions or to report an Adverse Event:
Contact Medical Information at: 888-838-2872, option 3, then, option 4
Live calls received: M – F, 9:00 AM – 5:00 PM Eastern Time, Voicemail: 24 hrs./day, 7 days/week 24 hrs. /day, 7 days/week, or by email at druginfo@tevapharm.com.

Product Quality Complaint-related Questions:
Contact Quality Assurance Services: 888-838-2872, option 4
Live calls received: M – F, 9:00 AM – 5:00 PM Eastern Time; Voicemail: 24 hrs./day, 7 days/week.

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.

This recall communication is from the 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.


Company Contact Information

Consumers:
888-838-2872, option 4
druginfo@tevapharm.com

Media:
Kelley Dougherty
973-658-0237

Product Photos
Click here for product photos

05/23/2022 Anagrelide by Teva- Provider

Teva Issues Voluntary Nationwide Recall of One Lot of Anagrelide Capsules, USP 0.5 mg Due to Dissolution Test Failure


FDA Publish Date: 05/23/2022

Teva Pharmaceuticals USA has initiated a voluntary nationwide recall of a single lot of Anagrelide Capsules, USP 0.5 mg (Lot number GD01090), to the consumer level in the United States. This voluntary recall was initiated due to a dissolution test failure detected during routine stability testing. No other lots are impacted.

Administration of this product with lower dissolution – taking longer to dissolve once ingested — may result in decreased effectiveness or ineffectiveness of the drug to exert its platelet-reducing effect. 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 in the body could increase the risk of clotting (blood coagulation), and clotting or bleeding events such as a heart attack or stroke, which could be life-threatening. To date, Teva has not received any product quality complaints or adverse event reports, of this nature, for the recalled lot.

Anagrelide capsules are indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate
associated symptoms including thrombo-hemorrhagic events. Information about the affected lot is listed in the table below. It is packed in bottles with 100 capsules. Teva distributed 4,224 bottles nationwide from 07-30-2020 through 09-02-2020 to its wholesale, distributor, and retail customers under the label for Teva Pharmaceuticals USA, Inc.

Teva notified its customers on May 11, 2022, alerting them that the lot was recalled and requesting that they return impacted product. Instructions for returning recalled product and receiving a credit are given in the customer recall letter (Anagrelide Recall 05 2022 Direct Accounts Letter Consumer Level 20 MAY 2022.pdf) and consumer recall letter (Anagrelide Recall 05 2022 _Patient Letter 20 MAY 2022.pdf) released by Teva.

Consumers with questions or concerns should first consult with their health care provider(s). To report an Adverse Event or Quality Complaint, or if you have Medical Related Questions, please use the following contact information:

Medical-related Questions or to report an Adverse Event:
Contact Medical Information at: 888-838-2872, option 3, then, option 4
Live calls received: M – F, 9:00 AM – 5:00 PM Eastern Time, Voicemail: 24 hrs./day, 7 days/week 24 hrs. /day, 7 days/week, or by email at druginfo@tevapharm.com.

Product Quality Complaint-related Questions:
Contact Quality Assurance Services: 888-838-2872, option 4
Live calls received: M – F, 9:00 AM – 5:00 PM Eastern Time; Voicemail: 24 hrs./day, 7 days/week.

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.

This recall communication is from the FDA


Company Contact Information

Consumers:
888-838-2872, option 4
druginfo@tevapharm.com

Media:
Kelley Dougherty
973-658-0237

Product Photos
Click here for product photos

04/22/2022 Accupril® by Pfizer- Member

Pfizer has posted a lot recall of Accupril® (quinapril hydrochloride [HCl]).

About this recall:
Pfizer is voluntarily recalling five (5) lots of Accupril (quinapril HCl) tablets distributed by Pfizer to the patient
(consumer/user) level due to the presence of a nitrosamine, N-nitroso-quinapril, observed in recent testing above
the Acceptable Daily Intake (ADI) level.

Accupril is indicated for the treatment of hypertension, to lower blood pressure. Accupril is also indicated in the
management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digoxin. To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall.

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. Although long-term ingestion of N nitroso quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to
patients taking this medication. Patients currently taking the products should consult with their doctor or healthcare provider about alternative treatment options for them.

The NDC, lot number, expiration date, configuration details, and photos for the recalled products are available at
the FDA Recall Notification link on the following page.

Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if
they have the affected product. Patients with the affected product should contact Sedgwick at 888-345-0481
(Mon.-Fri. 8:00 am – 5:00 pm ET) for instructions on how to return their product and obtain reimbursement for
their cost.

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.

This recall communication is from the 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.

 

04/22/2022 Accupril® by Pfizer- Provider

Pfizer Voluntary Nationwide Recall of Lots of Accupril® (Quinapril HCl) Due to NNitroso-Quinapril Conten


FDA Publish Date: 04/22/2022

Pfizer is voluntarily recalling five (5) lots of Accupril (Quinapril hydrochloride [HCl]) tablets distributed by Pfizer to
the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-quinapril, observed in recent
testing above the Acceptable Daily Intake (ADI) level.

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.

Accupril is indicated for the treatment of hypertension, to lower blood pressure. Accupril is also indicated in the
management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digoxin. Accupril has a safety profile that has been established over 30 years. To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall. Pfizer believes the benefit/risk profile of the products remains positive based on currently available data. Although long-term ingestion of N-nitroso quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to
patients taking this medication. Patients currently taking the products should consult with their doctor or health
care provider about alternative treatment options for them.

The NDC, Lot Number, Expiration Date, and Configuration details for these products are indicated in the tables
below, and photos of the products are linked at the end of this press release. The product lots were distributed
nationwide to wholesalers and distributors in the United States (US) and Puerto Rico from December 2019 to April
2022.

Table 1. Accupril® (Quinapril HCl Tablets), 10 mg, 20 mg, and 40 mg

Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and
supply chain process. Pfizer has notified 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 above, 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. Please request they immediately cease distribution of the affected product and
promptly contact Sedgwick at 888-345-0481 (Mon.-Fri. 8:00 am – 5:00 pm ET) to obtain a Business Reply Form
(BRF) to initiate the return process.

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 above. If you have any of the
affected product lots in your inventory, please follow the instructions above for returning the product to Sedgwick.
Additionally, if you are aware of any patients to whom you dispensed the affected lots who still may have the
product in their possession, please ask them to return the product to you and then follow the instructions above
for returning the product to Sedgwick. To request replacement product for any Pfizer PAP or Pfizer IPAP product
you return, please contact 833-203-2776 (Mon.-Fri. 8 am-6 pm ET).

Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if
they have the affected product. Patients with the affected product should contact Sedgwick at 888-345-0481
(Mon.-Fri. 8:00 am – 5:00 pm ET) for instructions on how to return their product and obtain reimbursement for
their cost.

Healthcare professionals with questions regarding this recall can contact Pfizer using the below information.

Pfizer Medical Information 

Medical questions regarding the product

800-438-1985, option 3
(Mon.- Fri. 8 am-9 pm ET)
www.pfizermedinfo.com

Pfizer Drug Safety

Report adverse events and product complaints

800-438-1985, option 1
(24 hours a day; 7 days a week)

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.

This recall communication is from the FDA


Company Contact Information
Consumers:
Sedgwick
888-345-0481

Media:
+1 (212) 733-7410
PfizerMediaRelations@pfizer.com


Product Photos
Click here for product photos.

04/12/2022 Insulin Glargine by Mylan- Member

Mylan Pharmaceuticals has posted a lot recall of insulin glargine injection.

About this recall:
Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its Insulin Glargine (Insulin
glargine- yfgn) Injection, 100 units/mL (U-100), which is packaged in a 10 mL vial that is inside a carton. This
product is not the branded Semglee vial but the unbranded Insulin Glargine- yfgn vial. This batch is being recalled
due to the potential for the label to be missing on some vials.

What this means to you:
For patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), a
missing label on Insulin Glargine vials could lead to a mix-up of products/strengths, which may result in less
optimal glycemic control (either high or low blood sugar) which could result in serious complications. To date, no
adverse events related to this recall have been received for this product.

The product is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric
patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

If you have an unlabeled product, please contact Stericycle at 1-888-912-7084 for the documentation packet to
return product to Stericycle. Consumers with questions regarding this recall can contact Viatris Customer Relations
by 1-800-796-9526 or customer.service@viatris.com, Monday through Friday from 8 a.m. – 5 p.m. EST. 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 selecting prompt #2.

 

04/12/2022 Insulin Glargine by Mylan- Provider

Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), Due to the Potential for a Missing Label in the Batch


FDA Publish Date: 04/12/2022

Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its Insulin Glargine (Insulin
glargine-yfgn) Injection, 100 units/mL (U-100), which is packaged in a 10 mL vial that is inside a carton. This product
is not the branded Semglee vial but the unbranded Insulin Glargine-yfgn vial. This batch is being recalled due to
the potential for the label to be missing on some vials. The product information, batch number and expiry date
information are present on the carton.

This batch was manufactured by Biocon Sdn. Bhd. and was distributed by Mylan Specialty L.P. in the US between
December 9, 2021, and March 4, 2022. The recalled batch is as follows:

Risk Statement: For patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), a missing label on Insulin Glargine vials could lead to a mix-up of products/strengths, which may
result in less optimal glycemic control (either high or low blood sugar) which could result in serious complications.
To date, no adverse events related to this recall have been received for this product.

This recall does not pertain to the branded interchangeable biosimilar, Semglee® (insulin glargine-yfgn)
injection but to the unbranded interchangeable biosimilar Insulin Glargine-yfgn vial.

The product is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric
patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. The company has initiated the
2—0412-2022 Class 1 Insulin Glargine – Mylan Voluntary Recallrecall of batch BF21002800 and notified its distributors and retailers by letter and is arranging for return of all recalled products. Following are actions for wholesalers, retailers, and consumers:

Wholesaler: Immediately examine your inventory, quarantine, and discontinue distribution of the batch
subject to recall. In addition, if you have further distributed the product, please identify all customers,
including retail level customers, and provide a list of customers via Microsoft excel file to
mylan5889@sedgwick.com within 5 business days. Sedgwick will notify your retail level customers that
received the affected batch.

Retailer: Immediately examine your inventory, quarantine, and discontinue distribution of this batch.

Consumer: If you have an unlabeled product, please contact Sedgwick at 1-888-912-7084 for the
documentation packet to return product to Sedgwick.

Consumers with questions regarding this recall can contact Viatris Customer Relations by 1-800-796-9526 or
customer.service@viatris.com, Monday through Friday from 8 a.m. – 5 p.m. EST. 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.

This recall communication is from the FDA


Company Contact Information

Consumers:
Viatris Customer Relations
1-800-796-9526
customer.service@viatris.com

Media:
Jennifer Mauer
+1-724-514-1968
Jennifer.Mauer@viatris.com


Product Photos
Click here for product photos

03/22/2022 SYMJEPI by Adamis- Member

Adamis Issues Nationwide Voluntary Recall of Symjepi® (Epinephrine) Injection for Potential Manufacturing Defect

About this recall:

Adamis is voluntarily recalling certain lots of Symjepi (epinephrine) Injection 0.15 mg (0.15 mg/0.3 mL) and 0.3 mg (0.3 mg/0.3 mL) prefilled single-dose syringes to the consumer level. The batches (lots) in the table on the following page are being recalled due to the potential clogging of the needle preventing the dispensing of epinephrine. US WorldMeds (USWM) exclusively markets and distributes Symjepi in the United States (US), under license from Adamis.

Drug recalled (manufacturer): Symjepi (Adamis Pharmaceuticals)

NDCs impacted: 78670-0131-02,  78670-0130-02

What this means to you:

If a person is experiencing an allergic reaction and/or anaphylaxis and is unable to access life-saving epinephrine due to the syringe malfunction, it can lead to life threatening consequences including death. Although not confirmed to be related to the recall, there have been two different customer complaints on three syringes, regarding difficulty in dispensing the product, to date. However, neither US WorldMeds nor Adamis Pharmaceuticals has received, or is aware of, any adverse events related to this recall.

Symjepi is used for the emergency treatment of allergic reactions including anaphylaxis to stinging insects (bees, wasps, hornets, yellow jackets, and fire ants) and biting insects (mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances and other allergens, as well as anaphylaxis of unknown cause and exercise-induced anaphylaxis.

The products are packaged in 2-count prefilled single-dose syringes per carton and were distributed nationwide in the US. The products can be identified by the label containing the US WorldMeds name and logo pictured on the cartons linked on the following page at the FDA Recall Notification and by the NDCs, lot numbers, and expiration dates shown in the table on the following page.

Consumers that have products that are subject to this recall should stop using the products immediately and may either return or discard the recalled lots. Consumers with questions regarding this recall can call (888) 900-8796 or e-mail questions at medinfo@usworldmeds.com Monday through Friday from 8:00 am to 4:00 pm ET.

The recall encompasses all of the following batches, within expiry:

Product Strength NDC Lot Expiration
Symjepi (epinephrine) Injection 0.15 mg/0.3 mL 78670-0131-02 21101Y 11/30/2022
0.3 mg/0.3 mL 78670-0130-02 21041W 8/31/2022
21081W 11/30/2022
21102W 2/28/2023

 

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 or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

 

 

03/22/2022 SYMJEPI by Adamis- Provider

Adamis Issues Nationwide Voluntary Recall of Symjepi® (Epinephrine) Injection for Potential Manufacturing Defect


FDA Publish Date: 03/22/2022

Adamis Pharmaceuticals Corporation is voluntarily recalling certain lots of Symjepi (epinephrine) Injection
(0.15 mg/0.3 mL) and 0.3 mg (0.3 mg/0.3 mL) prefilled single-dose syringes to the consumer level. The batches in
the table below are being recalled due to the potential clogging of the needle preventing the dispensing of
epinephrine. US WorldMeds (USWM) exclusively markets and distributes Symjepi in the United States (US), under
license from Adamis, the New Drug Application (NDA) holder. USWM will handle the entire recall process for
Adamis, with Adamis oversight. Symjepi is manufactured and tested for Adamis by Catalent Belgium S.A.

Risk Statement: If a person is experiencing an allergic reaction and/or anaphylaxis and is unable to access lifesaving epinephrine due to the syringe malfunction, it can lead to life threatening consequences including death. Although not confirmed to be related to the recall, there have been two different customer complaints on three syringes, regarding difficulty in dispensing the product, to date. However, neither US WorldMeds nor Adamis
Pharmaceuticals has received, or is aware of, any adverse events related to this recall.

The recall encompasses all of the following batches, within expiry:

Product Strength NDC Lot Expiration
Symjepi (epinephrine) Injection 0.15 mg/0.3 mL 78670-0131-02 21101Y 11/30/2022
0.3 mg/0.3 mL 78670-0130-02 21041W 8/31/2022
21081W 11/30/2022
21102W 2/28/2023

 

Symjepi is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging
insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets, and fire ants) and biting
insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g.,
radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.

The products are packaged in 2-count prefilled single-dose syringes per carton and were distributed nationwide
in the US and directly to customers and/or medical facilities. The products can be identified by the label containing
the US WorldMeds name and logo pictured on the cartons below.

US WorldMeds is notifying its customers by email, FDA alerts, and direct outreach. Consumers and institutions
that have products that are subject to this recall should stop using the products immediately and may either return
or discard the recalled lots. Consumers with questions regarding this recall can call (888) 900-8796 or e-mail
questions at medinfo@usworldmeds.com Monday through Friday from 8:00 am to 4:00 pm ET.

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.

This recall communication is from the FDA


Company Contact Information
Adamis Contacts:

Quality Compliance:
Craig Stenland -Quality Compliance Partners
858-361-6456
craigs@qualpartners.com

Investor Relations:
Robert Uhl- Managing Director
ICR Westwicke
619.228.5886
robert.uhl@westwicke.com

Consumers:
(888) 900-8796
medinfo@usworldmeds.com


Product Photos
Click here for product photos

03/22/2022 Accuretic by Pfizer- Member

Pfizer’s Voluntary Nationwide Recall of Accuretic™ (Quinapril HCl/
Hydrochlorothiazide [HCTZ]) and Quinapril HCl/HCTZ Tablets Due to N-NitrosoQuinapril Content

About this recall:

Pfizer is voluntarily recalling Accuretic (quinapril HCl/hydrochlorothiazide) tablets distributed by Pfizer as well as authorized generics distributed by Greenstone (quinapril HCl/HCTZ tablets) to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-quinapril, above the acceptable daily intake level. Pfizer has recalled six lots of Accuretic tablets and five lots of quinapril HCl/HCTZ tablets.

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.

Accuretic and quinapril HCl/HCTZ are indicated for the treatment of high blood pressure. Lowering blood pressure reduces the risk of cardiovascular events, primarily strokes and heart attacks. To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall. Although long term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication. Patients currently taking the products should consult with
their doctor about alternative treatment options.

The NDCs, lot numbers, and expiration dates for the recalled products are provided in the FDA Recall
Notification, linked on the following page. Photos of the products are also available at the FDA Recall Notification.

Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product. Patients with the recalled product should contact Sedgwick at 888-843-0247 (Monday through Friday 8:00 am to 5:00 pm ET) for instructions on how to return their product and obtain reimbursement for their cost.

Healthcare Professionals with questions regarding this recall can contact Pfizer using the below information.

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 selecting prompt #2.

 

03/22/2022 Accuretic by Pfizer- Provider

Pfizer’s Voluntary Nationwide Recall of Accuretic™ (Quinapril HCl/ Hydrochlorothiazide) and Quinapril HCl/ Hydrochlorothiazide Tablets Due to NNitroso-Quinapril Content


FDA Publish Date: 03/22/2022

Pfizer is voluntarily recalling Accuretic (quinapril hydrochloride [HCl]/hydrochlorothiazide [HCTZ]) tablets distributed by Pfizer as well as authorized generics distributed by Greenstone (quinapril HCl/HCTZ) to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-quinapril, above the acceptable daily intake (ADI) level. Pfizer has recalled six lots of Accuretic tablets and five lots of quinapril HCl/HCTZ tablets.

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.

These products are indicated for the treatment of hypertension. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. The products have a safety profile that has been established over 20 years of marketing authorization and through a robust clinical program. To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall. Pfizer believes the benefit/risk profile of the products remains positive based on currently available data. Although long term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication. Patients currently taking the products should consult with
their doctor about alternative treatment options.

The NDC, Lot Number, Expiration Date, and Configuration details for these products are indicated in the tables below and photos of the products can be found at the end of this press release. The product lots were distributed
nationwide to wholesalers and Distributors in the United States and Puerto Rico from November 2019 to March 2022.

Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified direct consignees by letter to arrange for return of any recalled product.

Table 1. Six recalled Accuretic (quinapril HCl/hydrochlorothiazide) lots in 90-count bottles

Table 2. Five recalled quinapril HCl/HCTZ lots in 90-count bottles

Wholesalers and distributors with an existing inventory of the lots, listed in the table above, 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.

Please request they immediately cease distribution of the affected product and
promptly contact Sedgwick at 888-843-0247 (Monday through Friday 8:00 am – 5:00 pm ET) to obtain a Business Reply Card (BRC) to initiate the return process.

Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if
they have the affected product. Patients with the affected product should contact Sedgwick at 888-843-0247 (Mon.-Fri. 8:00 am – 5:00 pm ET) for instructions on how to return their product and obtain reimbursement for
their cost.

Healthcare Professionals with questions regarding this recall can contact Pfizer using the below information.

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.

This recall communication is from the FDA


Company Contact Information

Consumers:
Sedgwick
888-843-0247

Media:
Media Relations
+1 (212) 733-7410
PfizerMediaRelations@pfizer.com


Product Photos
Click here for product photos

03/22/2022 Orphenadrine Citrate by Sandoz Inc. - Member

Sandoz Issues Nationwide Recall of 13 Lots of Orphenadrine Citrate 100 mg Extended-Release Tablets Due to the Presence of a Nitrosamine Impurity.

About this recall:
Sandoz Inc. (“Sandoz”) is initiating a voluntary recall of 13 lots of oral Orphenadrine Citrate 100 mg Extended Release (ER) Tablets to the consumer level. The presence of a nitrosamine impurity, which has the potential to be above the U.S. Food and Drug Administration (FDA)’s Acceptable Daily Intake (ADI) limit of 26.5 ng/day, was detected in the lots during recent testing. These 13 lots of Orphenadrine Citrate ER Tablets were shipped to customers from August 2019 to April 2021.

What this means to you:
Nitrosamines are substances that could cause cancer when present above the allowable exposure limits. While the use of products belonging to the recalled lots may represent a risk to patients, to date, Sandoz has not received any reports
of adverse events related to the presence of a nitrosamine impurity in the lots. Orphenadrine Citrate ER Tablets are used as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.

Consumers who have Orphenadrine Citrate ER Tablets being recalled should stop taking the recalled product and immediately consult with their physician to obtain another prescription. 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.

Consumers should contact Sedgwick by phone at 844-491-7869 Monday – Friday, 8:00 am – 5:00 pm EST, or email at sandoz4887@sedgwick.com to return the recalled product. This recall of Orphenadrine Citrate ER Tablets is specific to the lots listed at the link on the following page and does not apply to any other strengths of Sandoz Orphenadrine Citrate ER Tablets nor to other lot numbers of the product.

To report an adverse reaction, please contact Sandoz by phone at (800) 525-8747 or by email at qa.drugsafety@sandoz.com. Customer service agents are available Monday – Friday from 8:30 am to 5:00 pm ET.

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 selecting prompt #2.

 

03/22/2022 Orphenadrine Citrate by Sandoz Inc.- Provider

Sandoz Issues Nationwide Recall of 13 Lots of Orphenadrine Citrate 100 mg Extended-Release Tablets Due to the Presence of a Nitrosamine Impurity.


FDA Publish Date: 03/22/2022

Sandoz Inc. (“Sandoz”) is initiating a voluntary recall of 13 lots (listed below) of oral Orphenadrine Citrate 100 mg Extended Release (ER) Tablets to the consumer level. The presence of a nitrosamine (N-methyl-N-nitroso-2-[(2- methylphenyl)phenylmethoxy]ethanamine (NMOA or Nitroso-Orphenadrine)) impurity, which has the potential to be above the U.S. Food and Drug Administration (FDA)’s Acceptable Daily Intake (ADI) limit of 26.5 ng/day, was
detected in the lots during recent testing. These 13 lots of Orphenadrine Citrate ER Tablets were shipped to customers from August 2019 to April 2021.

Nitrosamines are substances with carcinogenic potential (substances that could cause cancer) when present above the allowable exposure limits. While the use of product belonging to the recalled lots may represent a risk to patients, to date, Sandoz has not received any reports of adverse events related to the presence of a nitrosamine impurity in the lot.

Orphenadrine Citrate ER Tablets are used as an adjunct to rest, physical therapy and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. The product is packaged in 100-count and
1000-count bottles and was distributed nationwide in the USA to wholesalers and distributors.

This recall of Orphenadrine Citrate ER Tablets is specific to the lots listed below and does not apply to any other strengths of Sandoz Orphenadrine Citrate ER Tablets nor to other lot numbers of the product. Any product returned that is not associated with this recall will be destroyed, and no credit will be issued.

Sandoz is notifying its wholesalers and distributors by mail and is arranging for the return of all recalled product. Wholesalers and distributors that have Orphenadrine Citrate ER Tablets subject to this recall should immediately
stop distribution of the recalled product and quarantine and return all recalled product in their inventory.

Consumers who have Orphenadrine Citrate ER Tablets being recalled should stop taking the recalled product and immediately consult with their physician to obtain another prescription. 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.

Table 1. Recalled Lots of Orphenadrine Citrate ER Tablets

NDC Number Lot Number Expiration Date Date of Manufacturer
0185-0022-01 JX6411 05/2022 5/24/2019
JX6413 05/2022 5/24/2019
KC0723 08/2022 8/21/2019
KC3303 08/2022 8/21/2019
KE4348 11/2022 8/21/2019
KE7169 11/2022 8/21/2019
KE4349 11/2022 8/21/2019
KL3199 03/2023 3/3/2020
KM0072 03/2023 3/3/2020
LA7704 10/2023 10/6/2020
LA7703 10/2023 10/6/2020
LA9243 11/2023 10/6/2020
0185-0022-10 KS3939 03/2023 3/3/2020

+ 1,000-count bottle

Retailers and consumers should contact Sedgwick directly by phone at 844-491-7869 or email at sandoz4887@sedgwick.com to return the recalled product. Representatives are available Monday – Friday, 8:00 am – 5:00 pm ET.

To report an adverse reaction, please contact Sandoz by phone at (800) 525-8747 or by email at qa.drugsafety@sandoz.com. Customer service agents are available Monday – Friday from 8:30 am to 5:00 pm ET.

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.

This recall communication is from the FDA


Company Contact Information

Consumers:
Sedgwick
844-491-7869
sandoz4887@sedgwick.com

Media:
Leslie Pott
201-354-0279

01/19/2022 Semglee by Mylan Pharmaceuticals- Member

Mylan’s Voluntary Recall of 1 Batch of Semglee® (insulin glargine injection)

About this recall:
Mylan is voluntarily recalling 1 batch of its non-interchangeable Semglee® (insulin glargine injection), 100 units/mL
(U-100), 3 mL prefilled pens, which are packaged in a labeled carton of 5 pens (NDC 49502-0196-75). The product
is being recalled due to the potential for the label to be missing on some prefilled pens within a labeled carton for
this particular batch. The recalled batch number is BF20003118 with an expiration date of August 2022.

What this means to you:
A missing label on Semglee prefilled pens, for patients receiving treatment with more than one type of insulin
(e.g., both short and long-acting insulin), could lead to a mix-up of products/strengths, resulting in administration
of the wrong insulin. Administration of the wrong insulin could result in either high or low blood sugar which could
lead to serious complications. To date, the company has not received any reports of adverse events related to this
recall.

This recall does not pertain to the recently launched interchangeable biosimilar, Semglee® (insulin glargineyfgn) injection or Insulin Glargine (insulin glargine-yfgn) injection.
The product is a long-acting human insulin analog indicated to improve blood glucose control in adults and
pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. It is packaged in
prefilled pens in cartons of 5 pens. The recalled product can be identified by the prefilled pens missing a white
label with the product name and dosage information affixed around the pen.
The company has initiated the recall of batch BF20003118 and is arranging for return of all recalled products.

Consumer: If you have an unlabeled product, please contact Stericycle at 1-888-843-0255 for the
documentation packet to return the product to Stericycle.

Consumers with questions regarding this recall can contact Viatris Customer Relations by 800-796-9526
or customer.service@viatris.com, Monday through Friday from 8 am to 5 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 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 selecting prompt #2

 

01/19/2022 Semglee by Mylan Pharmaceuticals- Provider

Mylan Pharmaceuticals Conducts a Voluntary Recall of One Batch of Semglee® (insulin glargine injection), 100 units/mL (U100), 3 mL Prefilled Pens, Due to the Potential for a Missing Label in the Batch


FDA Publish Date: 01/19/2022

Mylan is voluntarily recalling 1 batch of its non-interchangeable Semglee® (insulin glargine injection), 100 units/mL
(U-100), 3 mL prefilled pens, which are packaged in a labeled carton of 5 pens. The product is being recalled due
to the potential for the label to be missing on some prefilled pens within a labeled carton for this particular batch.

This batch was manufactured by Biocon Sdn Bhd. and distributed by Mylan Specialty in the United States (US)
between May 11, 2021 and November 11, 2021. The recalled lot is as follows: NDC # Name and Strength Size Batch # Expiry 49502-0196-75 Semglee® (insulin glargine injection), 100 units/mL (U-100) 3 mL prefilled pen BF20003118

NDC

 

Name and Strength

 

Size

 

Batch #

 

Expiration

 

49502-0196- 75 49502-0196- 75 3 mL prefilled pen BF20003118 BF20003118

 

Risk Statement:

A missing label on Semglee prefilled pens, for patients receiving treatment with more than one
type of insulin (e.g., both short and long-acting insulin), could lead to a mix-up of products/strengths, resulting in
administration of the wrong insulin. Administration of the wrong insulin could result in less optimal glycemic
control (either high or low blood sugar) which could lead to serious complications. To date, the company has not
received any reports of adverse events related to this recall.

This recall does not pertain to the recently launched interchangeable biosimilar, Semglee® (insulin glargineyfgn) injection, a branded product, or Insulin Glargine (insulin glargine-yfgn) injection, an unbranded product.

The product is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric
patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. It is packaged in prefilled pens
in cartons of 5 pens. The recalled product can be identified by prefilled pens missing a white label with the
product name and dosage information affixed around the pen.

The company has initiated the recall of batch BF20003118 and notified its distributors and retailers by letter and
is arranging for return of all recalled products. Following are actions for wholesalers, retailers, and consumers:

Wholesaler: Immediately examine your inventory, quarantine, and discontinue distribution of this lot. In
addition, if you have further distributed the product, please identify your retail level customers and
provide a list of customers via Microsoft excel file to mylan6069@sedgwick.com within 10 business days.
Stericycle will notify your retail level customers that received the affected batch.

Retailer: Immediately examine your inventory, quarantine, and discontinue distribution of this batch.

Consumer: If you have an unlabeled product, please contact Stericycle at 1-888-843-0255 for the
documentation packet to return product to Stericycle.

Consumers with questions regarding this recall can contact Viatris Customer Relations by 800-796-9526
or customer.service@viatris.com, Monday through Friday from 8 am to 5 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
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
Product Photos

Click here for product photos

01/12/2022 Metformin ER by Viona Pharmaceuticals- Member

Viona Issues Voluntary Nationwide Recall of Metformin HCl Extended-Release Tablets

About this recall:
Viona is voluntarily recalling twenty-three (23) lots of Metformin HCl ER Tablets, USP 750 mg at the consumer
level due to the detection of the NDMA impurity. The reason for the recall is an out of specification result found
for one (1) lot of the product’s long-term stability samples. In an abundance of caution, the firm has decided to
voluntarily recall 23 batches which they have determined having a valid shelf life within the United States (US)
market. This product was manufactured by Cadila Healthcare Limited, India for US distribution by Viona
Pharmaceuticals.

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. Patients who have received impacted lots of Metformin HCl ER Tablets, USP
750mg 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). Please visit the agency’s
website for more information. To date, neither Viona nor Cadila 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 plastic bottles of 100 tablets, under NDC 72578-0036-01.

The recalled lots of Metformin HCl ER Tablets, USP 750 mg are listed at the link 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. The tablets were distributed nationwide to distributors.

Consumers with questions regarding this recall can contact the recall processor, Inmar Pharmaceutical Services,
by phone at 1-855-249-3303, option 1; Monday through Friday (excluding holidays), 9 am to 5 pm, EST.

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

Viona is notifying its customers by email and mail (FedEx Overnight) and is arranging for the return of all recalled
products to our recall processor at the following address:

Inmar Pharmaceuticals Services-Recalls
3845 Grand Lakes Way,
Grand Prairie, Texas 75050

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

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.

 

 

01/12/2022 Metformin ER by Viona Pharmaceuticals- Provider

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


FDA Publish Date: 01/12/2022

Viona is voluntarily recalling twenty-three (23) lots of Metformin Hydrochloride (HCl) Extended-Release (ER)
Tablets, USP 750 mg at the consumer level. The reason for the recall is an out-of-specification result observed for
one lot of the product (M008132) “NDMA (by GC- MS/MS)” test at 17 months, 25°C/60%RH long-term stability
samples. In an abundance of caution, the firm has decided to voluntarily recall 23 batches which they have
determined to have a valid shelf life within the United States (US) market. This product was manufactured by Cadila
Healthcare Limited, Ahmedabad, India for US distribution by Viona Pharmaceuticals Inc.

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 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. To date, neither Viona nor Cadila 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 (plastic) bottles of 100 tablets, under NDC 72578-
0036-01. The recalled 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. The tablets were distributed nationwide to distributors.

Consumers with questions regarding this recall can contact the recall processor, Inmar Pharmaceutical
Services, by phone at 1-855-249-3303, option 1; Monday through Friday (excluding holidays), 9 am to 5 pm,
EST. Consumers should contact their physician or HCP if they have experienced any problems that may be related
to taking or using this drug product.

Product Name: Metformin HCl ER Tablets, USP 750 mg NDC: 72578-0036-01
Sr Number Batch Number Exp. Number
1.- M008130 06/2022
2.- M008131 06/2022
3.- M008132 06/2022
4.- M008133 06/2022
5.- M010080 07/2022
6.- M010081 07/2022
7.- M011029 08/2022
8.- M011030 08/2022
9.- M011031 08/2022
10.- M011032 08/2022
11.- M011304 08/2022
12.- M013394 09/2022
13.- M013395 09/2022
14.- M013396 09/2022
15.- M013966 09/2022
16.- M013967 09/2022
17.- M100831 12/2022
18.- M100832 12/2022
19.- M100833 01/2023
20.- M100834 01/2023
21.- M101267 01/2023
22.- M102718 01/2023
23.- M102719 01/2023

 

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

Viona is notifying its customers by email and mail (FedEx Overnight) and is arranging for the return of
all recalled products to our recall processor at the following address:

Inmar Pharmaceuticals Services-Recalls
3845 Grand Lakes Way,
Grand Prairie, Texas 75050

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

Product Photos
Click here for product photos

1/12/2022 Senna Syrup by Lohxa- Member

Lohxa LLC has posted a lot recall of Senna Syrup unit-dose cups.

About this recall:

Lohxa is voluntarily recalling one lot of Senna Syrup 8.8 mg/5 mL, unit-dose cups to the consumer level. The product is being recalled due to microbial contamination.

What this means to you:

Use of contaminated product by the elderly, patients with a weakened immune system, or patients at a higher risk of developing life-threatening inflammation of the heart, could lead to infections that are life-threatening. To date, Lohxa has not received any reports of adverse events related to this recall.

The product is used as a natural vegetable laxative for the relief of occasional constipation and is packaged into 5 mL unit-dose cups. The product is distributed into cases of 20 cartons packaged with 24 units each, NDC: 50268-0731-24. The affected Senna Syrup 8.8 mg/5 mL lot is AM1115S with expiration date of 01/2023. The product can be identified by the label shown at the FDA website linked on the following page. Product was distributed to AvKare (wholesaler) who may have further distributed this to clinics, hospitals, and healthcare providers.

Lohxa is notifying its distributors and customers by letter and is arranging for return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using the product and return it to place of purchase.

Consumers with questions regarding this recall can contact Lohxa by 800-641-5564 or by email to info@lohxa.com Monday to Friday from 9 am to 5 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 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 selecting prompt #2.

1/12/2022 Senna Syrup by Lohxa- Provider

Lohxa LLC is voluntarily recalling one lot of Senna Syrup 8.8 mg/5 mL, unit-dose cups to the consumer level. The product is being recalled due to microbial contamination.

Use of contaminated product by the elderly, patients with a weakened immune system, or patients at a higher risk of developing life-threatening inflammation of the heart, could lead to infections that are life-threatening. To date, Lohxa has not received any reports of adverse events related to this recall.

The product is used as a natural vegetable laxative for the relief of occasional constipation and is packaged into 5 mL unit-dose cups. The product is distributed into cases of 20 cartons packaged with 24 units each, NDC: 50268-0731-24. The affected Senna Syrup 8.8 mg/5 mL lot is AM1115S with expiration date of 01/2023. The product can be identified by the label shown in the product photos linked on the following page. Product was distributed to AvKare (wholesaler) who may have further distributed this to clinics, hospitals, and healthcare providers.

Lohxa is notifying its distributors and customers by letter and is arranging for return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using the product and return it to place of purchase.

Consumers with questions regarding this recall can contact Lohxa by 800-641-5564 or by email to info@lohxa.com Monday to Friday from 9 am to 5 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 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).

Company Contact Information
Consumers: Lohxa LLC

  • 800-641-5564
  • info@lohxa.com

Product Photos

  • Click here for product photos.

2021


2020


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