• The company is recalling dozens of human and animal drug products
  • It shut down its Quality program upon filing for bankruptcy
  • The recall affects products like artificial tears and Lidocaine ointment

A company is voluntarily recalling various drugs for humans and animals after filing for bankruptcy. It will reportedly no longer be able to guarantee the quality of the products.

Akorn Operating Company filed for bankruptcy on Feb. 23, according to the company announcement on the U.S. Food and Drug Administration (FDA) website. Since then, it has stopped all operations and terminated all its employees at U.S. sites. This move includes halting its Quality program.

"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," the announcement noted. "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."

There have been no reports of adverse reactions related to the use of the products.

The recall affects quite a handful of within-expiry products for human or animal use. For instance, the multi-page list of human products includes all lots and NDCs of its Artificial Tears, Lidocaine Ointment, Calcipotriene Scalp Solution, 0.005%, Clobetasol Propionate Shampoo, 0.05% and Fluticasone Propionate Nasal Spray, among dozens of other human products.

On the other hand, the list of affected veterinary products includes all lots and NDCs of products like Vetaket 100 mg/mL Injection (ketamine HCl) and Proparacaine HCl Ophthalmic Solution, 0.5%, among others.

These products are said to have been distributed nationwide, including to wholesalers, retailers and even to consumers via the internet. Distributors and consignees have been notified of the recall and are being requested to inform their customers of the issuance.

Customers with questions about the recall may contact Akorn at (800) 932-5676. On the other hand, those who have had problems — whether themselves or the animals in their care — relating to the use of the product are being advised to contact their health care provider or veterinarian.

Akorn had been "running at a loss for some time," company CEO Douglas Boothe wrote in a previous letter to employees about the layoff and company shutdown. In it, Boothe mentioned the hurdles that the company had been facing, including efforts to sell the company back in 2022 — efforts that unfortunately did not come to fruition.

"I truly regret that these actions have become necessary," Boothe noted.

Vial, Injection, Medicine, Vaccine,
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