Safety Report: Akorn human & animal drug products update - recalled due to discontinuation of the Quality program, USA

United States

The Akorn Trustee is initiating a voluntary recall of various within-expiry human and animal 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. The products were distributed nationwide to Wholesalers, Retailers, Manufacturers, Medical Facilities, and Repackagers and via the Internet to Consumers. Akorn has not received any reports of adverse events related to this recall.

You can see the lists of the recalled products at the following links:
- Human Products: www.fda.gov/media/167863/download
- Veterinary Products: www.fda.gov/media/167864/download

Only products listed in the attachments 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.

Risk Statement: 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 Operating Company LLC has 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 US Sites.

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.

For human drug products, adverse reactions or quality problems experienced with the use of these products may be reported. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care. For animals drug products, adverse reactions or quality problems experienced with the use of animal drug products may be reported.

Company name: Akorn Operating Company LLC
Brand name: Numerous Brands
Product recalled: Various human and animal drug products
Reason of the recall: As a result of a bankruptcy, the firm is removing several products from the market due to the discontinuation of the Quality program which would result in the company’s inability to assure that products meet the identity, strength, quality, and purity cha
FDA Recall date: May 04, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/update-akorn-issues-voluntary-nationwide-recall-various-human-and-animal-drug-products-within-expiry