Drug Recalls 2023

About this recall:

Invagen is voluntarily recalling 1 lot of Vigabatrin for Oral Solution, USP 500 mg to the consumer level (NDC 69097-0964-53; lot NB301030; expiry 03/2025). Vigabatrin for Oral Solution, USP 500 mg has been found to have issues with the seal of the foil pouch allowing for powder leakage from the pouch. This medication is packaged in foil pouches, each containing 500 mg of Vigabatrin.

The product is used for the treatment of refractory complex partial seizures as add-on therapy in patients 2 years of age and older who have not responded adequately to several alternative treatments.

What this means to you:

If the seal on the pouch is not working, it may lead to the leakage of powder outside the pouch. This results in a lower amount of medicine inside the pouch and the potential for underdosing of the drug. The population at risk is primarily infants and young children. In those patients, the potential exists that inaccurate dosing might result in a serious adverse event (for example: breakthrough seizures) requiring medical assistance.

Invagen is coordinating the return of all recalled products. Consumers in possession of recalled Vigabatrin for Oral Solution, USP 500 mg are instructed to return the recalled drug to the place of purchase. Consumers with questions regarding this recall can contact Cipla by phone number 844-CIPLAUS (844-247-5287) Monday to Friday 8:30 AM to 5:00 PM EST, or email cipla.cs@cipla.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using the recalled drug.

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.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/invagen-pharmaceuticals-issues-voluntary-nationwide-recall-vigabatrin-oral-solution-usp-500mg-due

FDA contact information for reporting adverse events/quality complaints can be reached online at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

About this recall:

Insight is voluntarily recalling 2 lots of Ting® 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder to the consumer level. A recent review found that samples from 2 lots of the product contained elevated levels of benzene due to the propellant that sprays the product out of the can. Benzene is not an ingredient in any Ting® Antifungal Spray products. The recalled lots of Ting® have an NDC of 63736-532-05 and are identified as lot# 0H88645 (expiration: July 31, 2024) and lot# 0B88345 (expiration: February 29, 2024).

Ting® 2% Miconazole Nitrate Athlete’s Foot Spray is available over-the-counter (OTC) and is effective in the treatment of most athlete’s foot, jock itch, and ringworm. It also relieves itching, scaling, burning, and discomfort that can accompany athlete’s foot and jock itch.

What this means to you:

Benzene is found throughout the environment; however, it is classified as a substance that could increase your risk for cancer. Exposure to benzene can occur by the lungs, the mouth, or through the skin. Benzene could potentially increase the risk for leukemia, bone marrow cancer, and blood disorders which can be life threatening. Humans have daily exposures to benzene both indoors and outdoors from multiple sources. Insight is recalling these products out of an abundance of caution. To date, no serious adverse events related to this recall have been reported to Insight.

Insight will offer reimbursement for consumers who have purchased a recalled lot. Product is packaged in green and white aerosol cans with lot numbers listed on the bottom of the can. Consumers can contact Insight via e-mail at medicalaffairs@prestigebrands.com, at https://www.prestigebrands.com/contact, or by phone at (800) 344-7239 on Monday through Friday 8:30 am to 5:30 pm Eastern Standard Time to receive a full refund by providing a picture of the bottom of the can of the recalled lot. Consumers that have product which is being recalled should stop using the product immediately and appropriately discard after taking the picture. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this spray 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.

Date: 11/27/2023

About this recall:

Novartis is conducting a voluntary nationwide recall at the consumer level of 2 lots of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the United States (US) due to crystal formation observed in some bottles. Crystallization could potentially result in incorrect dosing. The issue was identified during an investigation of crystallization in a different lot of Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL. No other Sandimmune formulations 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. The recalled lots of Sandimmune® Oral Solution has an DNC of 0078-0110-22 and is identified as lot# FX 001500 with an expiration of 9/30/2024 and lot# FC001582 with an expiration date of 9/30/2024.

Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL, packaged in 50 mL bottles, is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents.

What this means to you:

Crystallization of cyclosporine in Sandimmune Oral Solution is likely to result in non-uniform distribution of the cyclosporine in the product, resulting in under-dosing or over-dosing. There is a reasonable probability that under-dosing may result in lower exposures and decrease in efficacy which could ultimately lead to graft rejection and graft loss in transplant patients. Furthermore, over-dosage may manifest itself as cyclosporine toxicity in the long term if overexposure continues.

Novartis is notifying its distributors via a recall notification letter and is arranging for return of the recalled lot from distributors, retailers, and consumers. Additionally, Novartis is notifying health care providers who have prescribed this product to contact their patients. Consumers that have bottles from the recalled lot of Sandimmune Oral Solution (cyclosporine oral solution, USP), 100mg/mL, should contact their health care provider.

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.

Date: 11/21/2023

About this recall:

Bayer is voluntarily recalling 1 lot of Vitrakvi® (larotrectinib) oral solution 20 mg/mL in 100 mL glass bottles to the consumer/user level. The recall is due to contamination that was found during testing of the product. Contamination was from the fungus Penicillium brevicompactum. The recalled lot of Vitrakvi has an NDC of 50419-0392-01 and is identified as lot# 2114228 with an expiration date of February 29, 2024.

Vitrakvi is FDA-approved for the treatment of solid tumors that are NTRK gene fusion positive. Therefore, it is expected that patients receiving this medication may have a suppressed immune system.

What this means to you:

Cases of severe disease caused by similar fungus species to Penicillium brevicompactum have occurred, especially in patients whose immune systems are suppressed. Therefore, the potential exists that ingestion of Penicillium brevicompactum in patients with underlying immune system suppression could result in serious fungal infections of the blood or pneumonia that can be life-threatening.

Consumers who have the recalled Vitrakvi product should immediately stop use of this particular lot and contact their healthcare provider if they have any questions, concerns, or have experienced any problems related to the recalled drug. Patients or prescribers who have questions regarding the recall can contact Bayer Medical Information Call Center at 888-842-2937, Monday to Friday between the hours of 8:30 a.m. and 8:00 p.m. Eastern Standard Time. Alternatively, patients with general questions regarding this recall can contact Qualanex via e-mail at Recall@qualanex.com or toll free at 888-280-2043, Monday to Friday between the hours of 7 a.m. and 4 p.m. Central Standard Time.

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.

Date: 11/17/2023

At Magellan Rx Management, we want to help you receive the best possible care.

About this recall:

KinderFarms is voluntarily recalling all lots of KinderMed Infants’ Pain & Fever oral suspension (160 mg/5 mL of acetaminophen; NDC 82673-0096-02) and KinderMed Kids’ Pain & Fever oral suspension (160 mg/5 mL of acetaminophen; NDC 82673-0097-04) to the retail and consumer level. These over-the-counter (OTC) products are being voluntarily recalled due to acetaminophen instability as testing showed some lots were not within range and thereby may pose a health risk.

Acetaminophen is the active ingredient in many pain-relieving medicines.

What this means to you:

As a result of acetaminophen levels being outside of the expected range, the product may lead to adverse effects, such as stomach pain, nausea, vomiting, or jaundice (yellowing of the skin or eyes) at higher doses. The company has not received any reports of serious adverse events from either of these products to date. No other KinderFarms products are impacted by this recall.

Consumers who purchased either of these products should stop using them and may return the product to the place of purchase for a full refund. Consumers with questions may contact the company at consumerrelations@kinderfarms.com or 800-996-2930 from 6:00 AM to 5:00 PM (Pacific Time).

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.

Date: 11/01/2023

At Magellan Rx Management, we want to help you receive the best possible care. Visit our drug recall site for details: https://www1.magellanrx.com/drug-recalls/.

About this recall:

Cardinal Health is initiating a voluntary recall for all lots of the following ophthalmic products supplied by Velocity to the consumer level: Eye Irritation Relief, Dry Eye Relief, and Lubricant Eye Drops (NDCs: 70000-0087-01, 70000- 0089-01, 70000-0090-01, 70000-0090-02, 70000-0088-01, 70000-0587-01). The recall is due to insanitary conditions in the manufacturing facility and positive bacterial test results from sampling of drug production areas.

These products are available over the counter (OTC) for temporary relief of burning and irritation due to dryness of the eye and for use as a protectant against further irritation. The eye drops also can relieve redness of the eye due to minor eye irritations.

What this means to you:

For those patients who use these products, there is a risk for eye infections that could result in partial vision loss or blindness. These products should be sterile. Eye drops have a higher risk as applying to the eyes bypasses some of the body’s natural defenses.

Consumers should stop using the recalled eye drop products and may return any of the above listed products to the place of purchase. Consumers with questions regarding this recall can contact Sedgwick by phone at 1-855- 215-4940 (8:00 am to 5:00 pm EST Monday through Friday) or by email at Cardinalhealth7720@sedgwick.com. Consumers who have signs or symptoms of an eye infection after using these products should talk to their healthcare provider or seek medical care immediately.

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.

Date: 11/01/2023

At Magellan Rx Management, we want to help you receive the best possible care. Visit our drug recall site for details:  https://www1.magellanrx.com/drug-recalls/.

About this recall:

The Harvard Drug Group, doing business as Major® and Rugby®, is initiating a voluntary recall for all lots (batches) of Polyvinyl Alcohol, 1.4% Lubricating Eye Drops (NDC 00536-1325-94) and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%; NDC 00536-1282-94) supplied by Velocity to the consumer level. The recall is due to insanitary conditions in the manufacturing facility and positive bacterial test results from sampling of drug production areas.

These products are available over the counter (OTC) for temporary relief of discomfort due to irritation of the eye or due to exposure to wind and sun. The eye drops also protect against further irritation and can relieve dryness of the eye.

What this means to you:

For those patients who use these products, there is a risk for eye infections that could result in partial vision loss or blindness. These products should be sterile. Eye drops have a higher risk as applying to the eyes bypasses some of the body’s natural defenses.

Consumers should stop using the recalled eye drop products and may return any of the above listed products to the place of purchase. Consumers with questions regarding this recall can contact Sedgwick by phone at 1-866-891-1981 (8:00 am to 5:00 pm EST Monday through Friday) or by email address  at harvarddrug8430@sedgwick.com. Consumers who have signs or symptoms of an eye infection after using these products should talk to their healthcare provider or seek medical care immediately.

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.

KVK-Tech, Issues Voluntary Nationwide Recall of One Lot of Betaxolol Tablets, USP 10 mg as a Precautionary Measure Due to a Single Foreign Tablet Found During the Line Clearance After the Batch was Packaged

Date: 10/3/2023

At Magellan Rx Management, we want to help you receive the best possible care. Visit our drug recall site for details: https://www1.magellanrx.com/drug-recalls/.

About this recall:
KVK-Tech is voluntarily recalling 1 lot of Betaxolol Tablets, USP 10 mg, White, Round, film coated biconvex tablets, debossed “K” above bisect “13” on one side and plain on the other side” to the consumer level. The batch was distributed nationwide to wholesalers and retailers. The batch is being recalled as a precautionary measure due to a single Oxycodone HCl tablet 5 mg foreign tablet found on the packaging line during the line clearance after the subject batch was packaged.

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.

Betaxolol tablets are used for the treatment of hypertension (high blood pressure).

What this means to you:
The betaxolol package insert warns about slowing in the heart rate in elderly patients which is likely to be exacerbated by inadvertent opioid administration. Additionally, some patients prescribed low-dose betaxolol might be have compromised heart and lung function that is also likely to be exacerbated by an opioid. Furthermore, there are minor differences in appearance between betaxolol 10 mg tablets and oxycodone 5 mg tablets, not likely to be noticed by a regular user of the 10 mg betaxolol tablet. Specific patient populations such as those with opioid use disorder (OUD) or at risk of OUD, infants, children, and the elderly are likely to be negatively affected by inadvertently receiving an opioid, especially if a substantial number of oxycodone tablets have been introduced into a bottle labeled as betaxolol. Therefore, inadvertent exposure to a controlled substance, such as oxycodone, in that patient population is likely to result in significant slowing in breathing, known as respiratory depression, which is a serious health risk

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 the 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.

VistaPharm Issues Voluntary Nationwide Recall of Sucralfate Oral Suspension, 1g/10mL Due to Microbial Contamination Identified as Bacillus Cereus

Date: 09/22/2023

At Magellan Rx Management, we want to help you receive the best possible care. Visit our drug recall site for details: https://www1.magellanrx.com/drug-recalls/.

About this recall:
VistaPharm is voluntarily recalling one (1) lot of Sucralfate Oral Suspension, 1g/10mL, to the consumer level, due to Bacillus cereus contamination in the product. 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 as an antiulcer therapeutic and is packaged in a 16oz (414mL) PET Bottle with NDC 66689-305-16. The affected Sucralfate Oral Suspension lot is number 810300 with an expiration Date of October 31, 2023. The product can be identified with its product name Sucralfate Oral Suspension 1g per 10mL, with the product Lot No 810300 and expiration date of October 31, 2023, at the bottom right side of label. This Sucralfate Oral Suspension Lot was distributed Nationwide to three (3) distributors by wholesale.

What this means to you:
Consumers with questions regarding this recall can contact Inmar at 1-800-967-5952 or by email to rxrecalls@Inmar.com. Office hours are 9am to 5pm EST Monday through Friday. 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 the 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.

Scynexis Issues a Voluntary Nationwide Recall of Brexafemme® (ibrexafungerp tablets) Due to Potential for Cross Contamination with a Non-Antibacterial ßlactam Drug Substance

Date: 09/28/2023

At Magellan Rx Management, we want to help you receive the best possible care. Visit our drug recall site for details: https://www1.magellanrx.com/drug-recalls/.

About this recall:
Scynexis is conducting a voluntary nationwide recall of 2 lots of Brexafemme (ibrexafungerp tablets) to the consumer level in the US market due to potential cross contamination with a non- antibacterial ß-lactam drug substance in the ibrexafungerp citrate used to manufacture the Brexafemme tablets. During a review of manufacturing equipment and cleaning activities at a supplier, SCYNEXIS Scynexis was made aware of potential cross-contamination risk with a non-antibacterial beta-lactam drug substance. This press release provides additional details on the voluntary product recall recently disclosed by Scynexis.

The potential cross contamination with a non-antibacterial beta-lactam drug substance could lead to hypersensitivity reactions such as swelling, rash, urticaria and anaphylaxis, a potentially life-threatening adverse reaction. To date, Scynexis has not received any reports of adverse events established to be due to the possible beta-lactam cross contamination.

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.

Brexafemme is an antifungal product indicated for the treatment of vulvovaginal candidiasis (VVC) and the reduction of the incidence of recurrent vulvovaginal candidiasis (RVVC). Brexafemme is dispensed in a carton and packaged in blister packs with four 150-mg tablets (NDC 75788-115-04). Brexafemme tablet for oral administration is a purple, oval, biconvex shaped, film-coated tablet debossed with 150 on one side and SCY on the other side. The affected Brexafemme lots include the following lots and expiration dates: LF21000008 (expiration date 11/2023) and LF22000051 (expiration date 11/2025). The recalled lots were distributed nationwide to wholesalers across the US, beginning in December 2022.

What this means to you:
Consumers with questions regarding this recall can contact Sedgwick at 1-877-551-7154. Office hours: Monday to Friday, 8:00 AM to 5:00 PM ET.

Consumers should contact their 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 the 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.

Novartis Issues Voluntary Nationwide Recall of One Lot of Sandimmune® Oral Solution (Cyclosporine Oral Solution, USP), 100 mg/mL Due to Crystallization

Date: 09/11/2023

At Magellan Rx Management, we want to help you receive the best possible care. Visit our drug recall site for details: https://www1.magellanrx.com/drug-recalls/

About this recall:
Novartis is conducting a voluntary nationwide recall at the consumer level of one lot of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. No other Sandimmune formulations are impacted.

Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL, packaged in 50 mL bottles, is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents.

The affected lot number and expiration date is: FX001691 (expiration date 12/2025). This lot was distributed nationwide to wholesalers across the US, beginning in April 2023.

What this means to you:
Novartis is notifying its distributors via a recall notification letter and is arranging for return of the recalled lot from distributors, retailers and consumers. Additionally, Novartis is notifying health care providers who have prescribed this product to contact their patients. Consumers that have bottles from the recalled lot of Sandimmune Oral Solution (cyclosporine oral solution, USP), 100mg/mL, should contact their health care provider.

In the event that a patient experiences an adverse reaction or quality problem involving this product, they should immediately contact their health care provider and Novartis to report the event or finding. Patients or health care providers may call the Novartis customer interaction center at 888-NOW-NOVA (888-669-6682) from 8:30 AM – 5:00 PM ET Monday through Friday or may report an adverse event through https://www.novartis.com/reportExternal Link Disclaimer or usdrugsafety.operations@novartis.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 the 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.

Marlex Pharmaceuticals Issues Voluntary Nationwide Recall of Digoxin Tablets USP, 0.125mg and Digoxin Tablets USP, 0.25mg Due to Label Mix-Up

Date: 08/31/2023

At Magellan Rx Management, we want to help you receive the best possible care. Visit our drug recall site for details: https://www1.magellanrx.com/drug-recalls/.

About this recall:
Marlex Pharmaceuticals is voluntarily recalling one lot of Digoxin Tablets USP, 0.125mg and one lot of Digoxin Tablets USP, 0.25mg to the consumer level due to Label Mix-Up. Bottles of Digoxin Tablets, USP 0.125mg are incorrectly labeled and contain Digoxin Tablets USP, 0.25mg Tablets. Bottles of Digoxin Tablets USP, 0.25mg are incorrectly labeled and contain Digoxin Tablets USP, 0.125mg. 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.

Digoxin is used for the treatment of mild to moderate heart failure. It increases heart muscle contraction in pediatric patients with heart failure. Digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. The product is packaged as 100 tablets in white HDPE bottles and labeled as indicated below with NDC, lot and expiration date. Marlex Pharmaceuticals, Inc has not received any reports of adverse events related to this recall.

What this means to you:
Consumers/distributors/retailers that have Digoxin Tablets USP, 0.125mg and Digoxin Tablets USP, 0.25mg (lot# E3810 and lot# E3811) which are being recalled should stop using/return to place of purchase. Marlex Pharmaceuticals is notifying its distributors and customers by emails and is arranging for return of all recalled products (lot# E3810 and lot# E3811).

Consumers with questions regarding this recall can contact Marlex Pharmaceuticals by phone number 302-328-3355 or toll free 888-582-1953 on Monday – Friday from 8.30AM and 4:30PM, 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 the 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.

Lupin Pharmaceuticals Issues Voluntary Nationwide Recall of 2 Lots of Tydemy™ (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451mg and Levomefolate Calcium Tablets 0.451mg) Due to Out of Specification (OOS) Results at the 12-month Stability Time Point

Date: 07/31/2023

At Magellan Rx Management, we want to help you receive the best possible care. Visit our drug recall site for details: https://www1.magellanrx.com/drug-recalls/

About this recall:
Lupin Pharmaceuticals (Lupin) is voluntarily recalling two (2) lots of Tydemy (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451 mg and Levomefolate Calcium Tablets 0.451 mg) to the patient (consumer/user) level due to out of specification (OOS) test results at the 12-month stability time point. Specifically, one lot (L200183) tested low for ascorbic acid (an inactive ingredient) and high for a known impurity.

To date, Lupin has received no reports of adverse events related to either recalled batches. Regardless, Lupin is recalling these two batches because if there were a significant reduction in the amount of inactive content (ascorbic acid), this could potentially impact the effectiveness of the product which could potentially result in unexpected pregnancy.

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.

Tydemy is estrogen/progestin oral contraceptive (COC) indicated for use by women to prevent pregnancy and to raise folate levels in women who choose to use an oral contraceptive for contraception. Tydemy is packaged in 28’s blister. One such blister was then packed in a pouch along with one printed sleeve, one pack insert (with day label) and one oxygen absorber (Stabilox) sachet. The three pouches were packed in one carton.

What this means to you:
Patients taking Tydemy are advised to continue taking their medication and immediately contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.

Wholesalers, distributors and retailers that have Tydemy that is being recalled should discontinue distribution of the recalled product lots immediately.

Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (866) 480-8206 Monday – Friday 09:00 am to 05:00 pm EST. For reimbursement, please have the recalled lots returned to Inmar Rx Solutions, Inc.; the lot number can be found on the side of the carton. 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 the 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.

Cipla Issues Voluntary Nationwide Recall of 6 Batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) Due to Container Defect

Date: 07/07/2023

At Magellan Rx Management, we want to help you receive the best possible care. Visit our drug recall site for details: https://www1.magellanrx.com/drug-recalls/

About this recall:
Cipla Limited announced that its wholly-owned subsidiary, Cipla US, is voluntarily recalling 6 batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) manufactured in November 2021 to the consumer level. The company is initiating a recall in the US due to a market complaint for 1 single inhaler (Batch Number – IB20056), where leakage was observed through the inhaler valve. Out of an abundance of precaution, the above mentioned 6 batches manufactured using the same lot of valves are being recalled. The product is packaged in 17ml plain aluminum aerosol canisters integrated with a dose counter, coupled with a plastic actuator and dust cap. Each pack claims 200 metered inhalations. Associated codes are NDC-69097-142-60. These six batches were distributed Nationwide to wholesalers and retailers.

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 the treatment and prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise induced bronchospasm.

What this means to you:
There is a reasonable probability that failure to deliver the recommended dose to treat the respiratory symptoms of an acute asthma exacerbation such as wheezing, coughing, shortness of breath, and bronchospasms, due to device defect, may be life-threatening. There were no adverse events reported for Albuterol Sulfate Inhalation Aerosol 90 mcg related to this recall.
Consumers with questions adverse reactions or quality problems regarding these six batches can contact Cipla Customer Service at 844- CIPLAUS (844-247-5287) M-F 8:30-5:00 EST, or email cipla.cs@cipla.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 the 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.

Global Pharma Healthcare Issues Voluntary Nationwide Recall of Artificial Tears Lubricant Eye Drops Due to Possible Contamination

Date: 02/02/2023

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

Global Pharma has posted a full lot recall of Artificial Tears Lubricant Eye Drops.

About this recall:
Global PharmaHealthcare is voluntarily recalling all lots within expiry of their Artificial Tears Lubricant Eye Drops, distributed by /EzriCare and Delsam Pharma to the consumer level due to possible contamination. To date, there are 55 reports of adverse events including eye infections, permanent loss of vision, and a death with a bloodstream infection.

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.

Artificial Tears (carboxymethylcellulose sodium) Lubricant Eye Drops, in 10 mg in 1 mL, ½ fl oz (15 ml) bottles, are used as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun.

What this means to you:
Use of contaminated artificial tears can result in the risk of eye infections that could result in blindness.

Consumers with questions regarding this recall can contact the distributors: Aru Pharma/Ezricare, LLC by phone: 1-516-715-5181 or by e-mail: arupharmainc@yahoo.com from Monday to Friday, 11am to 4pm EST; or DELSAM Pharma LLC by phone: 1-866-826-1306 or by e-mail: delsampharma@yahoo.com from Monday to Friday from 11am to 4pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these over-the-counter 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 the 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.

Akorn Issues Voluntary Nationwide Recall of Various Human and Animal Drug Products Within Expiry Due to Company Shutdown

Date: 04/26/2023

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.
Akorn has posted a full lot recall of various human drug products.

About this recall:
Akorn Operating Company filed Chapter 7 bankruptcy on February 23, 2023. In connection with that filing, the company has ceased and shutdown all operations and terminated all its employees of all domestic United States (US) Sites. The Akorn Trustee is initiating a voluntary recall of various within-expiry human products as a result of the closures and discontinuation of the Quality activities of these marketed products. The discontinuation of the Quality program means the company will not be able to support or guarantee that the products will meet all intended specifications through the labeled shelf life of the product. Further distribution or use of any remaining product on the market should cease immediately.

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:
The discontinuation of the Quality program would result in the company’s inability to assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess which render the products adulterated. While specific risks to patients, from use of these adulterated products, cannot always be identified or assessed, it is also not possible to rule out patient risks resulting from the use of such products. Akorn has not received any reports of adverse events related to this recall.

The affected products are listed in Attachment I (human drugs) of the FDA Press Release. Only products listed in the attachment are affected by the recall. Products not included in the press are continuing to be monitored under a Quality Program and will remain on the market. The products were distributed nationwide to wholesalers, retailers, manufacturers, medical facilities, and repackagers and via the Internet to consumers.

Akorn is notifying its distributors and direct consignees by direct mailing and is requesting they further notify their customers/consumers/retailers. Akorn is requesting destruction of any recalled products. Consumers/distributors/retailers that have products which are being recalled should discard and contact their doctor.

Consumers with questions regarding this recall can contact Akorn at (800) 932-5676 during normal business hours (8am – 5pm CDT) Monday – Friday. A qualified medical professional will return your call within one business day. Consumers should contact their physician or their healthcare provider 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 the 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.

The Harvard Drug Group Issues Voluntary Nationwide Recall of Dronabinol Capsules, USP, 2.5 mg and Ziprasidone Hydrochloride Capsules, 20 mg Due to Label Mix‐up.

Date: 06/14/2023

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

The Harvard Drug Group has posted a lot recall of Dronabinol Capsules 2.5mg and Ziprasidone Hydrochloride Capsules
20mg.

About this recall:
The Harvard Drug Group is initiating a voluntary recall of a single lot of Dronabinol Capsules, USP, 2.5 mg and Ziprasidone Hydrochloride Capsules, 20 mg to the consumer level. The Harvard Drug Group received a customer
complaint from a distributor, that some unit dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg for Lot T04769. Accordingly, The Harvard Drug Group is recalling all of Lot T04769, Dronabinol Capsules, USP, 2.5 mg, which may be in outer cartons that read Dronabinol Capsules, USP, 2.5 mg OR Ziprasidone Hydrochloride Capsules, 20 mg.

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.

Ziprasidone Hydrochloride Capsules, 20 mg, is used for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder.

Dronabinol Capsules, USP, 2.5 mg, is used as: (1) an anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS), and (2) nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

What this means to you:
There is a reasonable probability that patients who mistakenly take Dronabinol Capsules, USP, 2.5 mg instead of Ziprasidone Hydrochloride, 20 mg capsules, can experience serious adverse events from 1) missing their
ziprasidone dose and 2) taking an unexpected dose of Dronabinol. Patients missing doses of Ziprasidone can experience exacerbation of underlying health issues such as bipolar disorder, schizophrenia, agitation,
aggression, or delirium. This can result in mental illness instability with possible consequences of self‐harm or harm to others which could result in medical or psychiatric hospitalization. Taking an unexpected dose of Dronabinol may cause mental and cognitive effects that result in impairment of mental and/or physical abilities. This can include worsening of symptoms in patients with mental illness disorders and limitation of patients’ abilities to safely complete hazardous activities (e.g., driving a motor vehicle, operating machinery).

Elderly patients or those taking other medications that affect mental function may be particularly at risk for these reactions. The Harvard Drug Group has not received any reports of adverse events related to this recall.
Consumers with questions regarding this recall can contact Sedgwick, Inc. by phone at 1‐888‐759‐6904 (8:00am‐ 5:00pm EST Monday through Friday) or by email address harvarddrug6068@sedgwick.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 the 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.

Camber Pharmaceuticals, Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750mg/5mL Due to Potential Bacillus Cereus Contamination in the Product

Date: 03/31/2023

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

Camber Pharmaceuticals has posted a lot recall of Atovaquone Oral Suspension.

About this recall:
Camber Pharmaceuticals is voluntarily recalling lot # E220182 of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential of bacillus cereus contamination in the product.

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.

Atovaquone Oral Suspension, USP is indicated for prevention and treatment of Pneumocystis jiroveci pneumonia (PCP) in adults and children 13 years of age and older who cannot tolerate other medicines, such as trimethoprim-sulfamethoxazole. The product is packaged in 210mL HDPE bottle in a mono carton.

What this means to you:
In the population most at risk, the immunocompromised population, there is a reasonable probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life threatening infections such as inflammation of the heart and soft tissue infections causing death of the tissue. To date, Camber has not received any reports of adverse events related to this recall.

Camber Pharmaceuticals, Inc. is notifying its distributors and customers by our Reverse Logistics Company, Inmar, by mailings and emails communications method and is arranging for returns of all recalled Atovaquone Oral Suspension, USP.

Consumers/distributors/retailers that have product which is being recalled should stop using/return to place of purchase/discard/contact their doctor, etc.

Consumers with questions regarding this recall can contact Inmar by phone at 1-877-597-0878 or email rxrecalls@inmar.com, Monday – Friday, 9am – 5pm Eastern 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 the 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.

Ascend Laboratories. Issues Voluntary Nationwide Recall of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg, due to the Detection of N-Nitroso-dabigatran (NDAB) Impurity

Date: 03/22/2023

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

Ascend Laboratories has posted a lot recall of Dabigatran Etexilate Capsules.

About this recall:

Ascend Laboratories is voluntarily recalling Dabigatran Etcxilate Capsules USP 75 mg and 150 mg to the consumer/user level due to the presence of a nitrosamine. N-nitroso-dabigatran has been detected above the established Acceptable Daily Intake (ADI) level. To date, Ascend Laboratories LLC., has not received any reports of adverse events related to this recall.

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.

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:

Patients who have received impacted lots of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment. The product is used as an oral anticoagulant to lower the risk of stroke and blood clots.

Consumers with questions regarding this recall can contact Ascend Laboratories LLC. using the below information.

Contact Center Contact Information Area of Support Ascend Laboratories, LLC 877-272-7901, 24 hrs., 7 days a week To report adverse events and product complaints.

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. Customers with medical-related questions, who wish to report an adverse event, or quality issues about the products being recalled should contact Ascend Laboratories LLC., by phone at: 877- 272-7901, 24 hrs., 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 the 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.

Global Pharma Healthcare Issues Voluntary Nationwide Recall of Delsam Pharma Artificial Eye Ointment Due to Possible Microbial Contamination

Date: 02/24/2023

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

Global Pharma Healthcare has posted a lot recall of Delsam Pharma Artificial Eye Ointment.

About this recall:

Global Pharma Healthcare is voluntarily recalling Batch No. H29 of Artificial Eye Ointment, distributed by Delsam Pharma to the consumer level, due to possible microbial contamination. Additionally, some product packaging is leaking or may otherwise be compromised.

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.

Delsam Pharma Artificial Eye Ointment (mineral oil 15%, white petrolatum 83%, 3.5 grams / 1/8 oz.) is used as an eye lubricant and to relieve dryness of the eyes. The affected product is packaged in a white aluminum tube within a paper carton.

What this means to you:

Use of contaminated eye ointment may cause adverse events, including infection in the eye that could lead to blindness. To date, Global Pharma Healthcare has not received any reports of adverse events related to this product.

Global Pharma Healthcare is notifying the brand owner and importer of this product, Delsam Pharma, about this recall, and is requesting that wholesalers, retailers, and customers who have the recalled product should stop any use and discard the product safely and appropriately.

Consumers with questions regarding this recall can contact the distributor Delsam Pharma, LLC by phone at 1-866-826-1306 or by e-mail at delsampharma@yahoo.com from Monday to Friday from 11am to 4pm EST.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these over-the-counter 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 the 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.

IBSA Pharma Issues Voluntary Nationwide Recall of Select Lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution Due to Subpotency

Date: 02/01/2023

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

IBSA Pharma has posted a 27-lot recall of Tirosint®-Sol Oral Solution.

About this recall:

IBSA Pharma is voluntarily recalling 27 lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution to the consumer level. This voluntary recall has been initiated because these lots may be subpotent. The company’s analyses show a slight decrease below 95.0% of its labeled amount in levothyroxine sodium (T4) for some lots. This recall does not apply to TIROSINT® (levothyroxine sodium) capsules.

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.

TIROSINT®-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule. The dosage strength is identified on the box and the pouch and is associated with a distinct color. Each ampule bears a colored label with the dosage strength and the product name (TIROSINT®-SOL). For full prescribing information, visit www.TirosintSOL.comExternal Link Disclaimer.

What this means to you:

Patients being treated for hypothyroidism (underactive thyroid), who receive subpotent TIROSINT®-SOL, may experience signs and symptoms of hypothyroidism (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. Over- or under-treatment with TIROSINT® SOL may have negative effects on growth and development, cardiovascular function, bone metabolism, reproductive function, cognitive function, emotional state, gastrointestinal function, and glucose and lipid metabolism. Any patients including those who might be pregnant, newborn infants, or elderly patients, 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 date, IBSA Pharma has not received any reports of adverse events that have been determined to be related to this voluntary recall.

TIROSINT®-SOL is indicated for:

• Hypothyroidism – As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.

• Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression – As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

IBSA Pharma is proactively notifying its wholesalers, retailers, and healthcare providers to discontinue distribution of the product being recalled and is arranging for the return of all recalled products. Patients who are currently taking TIROSINT®-SOL should not discontinue use without contacting their healthcare provider for further guidance and/or replacement prescription.

Consumers and healthcare providers with questions regarding this recall can contact IBSA Pharma by phone number at 1-800-587-3513 Monday through Friday between the hours of 9:00 am to 7:00 pm (EST), or by e-mail at medinfo@ibsapharma.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 the 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.

Apotex Corp. Issues Voluntary Nationwide Recall of Brimonidine Tartrate Ophthalmic Solution, 0.15% Due to Cracks that Have Developed in Some of the Units Caps of the Bottles
Date: 03/02/2023

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 Corp. has posted a lot recall of Brimonidine Tartrate Ophthalmic Solution.

About this recall:
Apotex Corp. is initiating a voluntary recall at the Consumer level for 6 lots of Brimonidine Tartrate Ophthalmic
Solution, 0.15% . This recall is being initiated out of an abundance of caution due to cracks that have developed
in some of the units caps of Brimonidine Tartrate Ophthalmic Solution bottles. There is a possibility the broken
cap may impact sterility and if so, adverse events may occur.

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.

Brimonidine Tartrate Ophthalmic Solution is an alpha-adrenergic receptor agonist indicated for the reduction of
elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

What this means to you:
Apotex Corp. is notifying all impacted direct accounts (Wholesalers, Distributors, Warehousing Chains, Mail Order
Pharmacy and Long-Term Care Pharmacy) of this voluntary recall via email and mail (FedEx Standard Overnight)
and is arranging for return of all recalled product.

Patients who have received the identified lots or have questions regarding this recall should contact their
pharmacy. They should immediately contact their health care provider for medical advice and return the identified
lots to Inmar Rx Solutions by contacting at the phone number provided in this press release.

Wholesalers, Distributors, Warehousing Chains, Mail Order Pharmacy and Long-Term Care Pharmacy should
return the recalled product to the place of purchase. Anyone with an existing inventory of the recalled product should quarantine the recalled lots immediately. Customers who purchased the impacted product directly from
Apotex Corp. can call Inmar Rx Solutions at 1-855-275-1273 (9:00am – 5:00pm, EST Monday thru Friday), to
arrange for their return. Consumers with the impacted units of Brimonidine Tartrate Ophthalmic Solution, 0.15%, can contact Inmar RxSolutions at 1-855-275-1273, to receive a recall/return packet including the Recall Stock Response Form (or you may obtain this form from clsnetlink.com External Link Disclaimer).

Consumers with questions regarding this recall can contact Apotex Corp. by phone at 1-800-706-5575 (8:30am –
5:00pm, EST Monday thru Friday) or email address 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.

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 the 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.