Akorn Operating Company filed Chapter 7 bankruptcy on February 23, 2023. The company then ceased and shutdown all operations and terminated all its employees. The Akorn Trustee is recalling 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 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 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.
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