FDA MedWatch - Various Human and Animal Drug Products Within Expiry by Akorn

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TOPIC: Various Human and Animal Drug Products Within Expiry by Akorn: Recall - Due to Company Shutdown

AUDIENCE: Patient, Consumer, Health Professional, Veterinary Medicine, Pharmacy

ISSUE: 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. 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.

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 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.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: 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.

RECOMMENDATIONS: 

• Patients and consumers should contact their physician, their healthcare provider or veterinarian if they, or animals in their care, have experienced any problems that may be related to taking or using these drug products.

• Patients and consumers that have products which are being recalled should discard and contact their doctor.

• 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.

• Patients and consumers with questions regarding this recall can contact the company.

Health professionals, patients and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

For animal drug products, adverse reactions or quality problems experienced with the use of animal drug products may be reported to FDA’s Center for Veterinary Medicine Adverse Event Reporting program by completing an online Form FDA 1932a available at www.fda.gov/reportanimalae.

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