Following its decision to shut down, Akorn Pharmaceuticals has issued a voluntary recall of its medications. The list of recalled products, which consists of 75 human medications and 9 veterinary drugs, is unrelated to any adverse events but is related to the company’s Chapter 7 bankruptcy filing in February, in which they decided to close.
What is closing?
As part of the shutdown, their quality programme will be shut down, which means “the company will not be able to support or guarantee that the products will meet all intended specifications through the labelled shelf life of the product,” according to a press release from the company. Products from Akorn were sold online to wholesalers, retailers, manufacturers, hospitals, repackagers, and consumers.
Distributors are being notified of the recall by mail from the corporation, and they are being urged to do so. They further suggest that customers stop using the recalled product and notify their doctor. Customers can contact an Akorn at 800-932-5676, which is staffed Monday through Friday from 8 a.m. to 5 p.m. Central Daylight Time, with any queries regarding the recall.
The U.S. Food & Drug Administration accepts reports for human pharmaceuticals online or by phone at 800-332-1088. Consumers can complete out the FDA 1932a form and email it to the FDA’s Centre for Veterinary Medicine Adverse Event Reporting programme to report adverse events related to animal drugs.
Drugmaker Akorn Recalls All Of Its Products After Bankruptcy
Issues confronting Akorn
According to The Herald & Review, Illinois-based Akorn abruptly fired 400 employees over a Zoom call in February. Akorn’s president and chief executive officer, Douglas Boothe, informed the staff of the closure. However, the business has encountered numerous issues. According to Reuters, the FDA sent warning letters to Akorn in 2019 as a result of a plant’s failure to follow protocol to prevent the contamination of pharmaceuticals.
According to Fierce Pharma, it also filed for Chapter 11 bankruptcy in 2020 and was in buyout negotiations with German pharmaceutical company Fresenius for $4.3 billion in 2018. However, Fresenius withdrew from the negotiations in 2018 after alleged fraud in Akorn’s medication development and manufacturing.