Human, animal drug recall announced due to company shutdown

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Drug recall overview: 

• Who: Akorn has issued a recall of various human and animal drug products.
• Why: The recall was issued as the firm has gone bankrupt and is no longer able to ensure the quality of the products.
• Where:  The drug recall is active in the United States.

Akorn has issued a recall of various human and animal drug products as the firm has gone bankrupt and is no longer able to ensure the quality of the products.

The recall was issued on April 26 on the U.S. Food & Drug Administration (FDA) website. It applies to more than 75 human drug products of various types, and nine veterinary medicines.      

According to the recall, as a result of a bankruptcy, the firm is removing the products from the market due to the discontinuation of its Quality program, which would result in its inability to assure that they meet the identity, strength, quality, and purity characteristics that they are purported to possess. 

“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,” the company said.

While specific risks to patients from use of the adulterated products cannot always be identified or assessed, it is also not possible to rule out patient risks resulting from their use, the company said. Akorn has not received any reports of adverse events related to the recall so far, it said. 

The company is not facing legal action over the recall, but Top Class Actions follows recalls closely as they sometimes lead to class action lawsuits.

Akorn has filed for bankruptcy

Akorn Operating Company LLC filed for Chapter 7 bankruptcy Feb. 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 sites, it said. 

“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 online direct to consumers. Akorn is notifying its distributors and direct consignees by direct mail and is requesting they further notify their customers. 

“Akorn is requesting destruction of any recalled products. Consumers/distributors/retailers that have products which are being recalled should discard and contact their doctor.”

Meanwhile, Camber Pharmaceuticals Inc. has recalled some of its Atovaquone oral suspension pneumonia medication due to a potential Bacillus cereus contamination.

Are you affected by this drug recall? Let us know in the comments! 

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