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

On April 26, 2023, Akorn Operating Company LLC has initiated 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. Akorn has not received any reports of adverse events related to this recall.

Consumers with questions regarding this recall can contact Akorn at (800) 932-5676, Monday – Friday, 8am – 5pm CDT.

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: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htmor 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

Source:

1. FDA MedWatch. “Recalls, Market Withdrawals, & Safety Alerts”. Retrieved May 1, 2023 from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/akorn-issues-voluntary-nationwide-recall-various-human-and-animal-drug-products-within-expiry-due?utm_medium=email&utm_source=govdelivery