In the wake of Akorn Operating Company LLC (Akorn Pharmaceuticals) officially shutting down all operations and employment across the United States, the company has also initiated a voluntary recall of a number of its within-expiry human and animal products.
Give me some background on this.
Akorn filed for Chapter 7 bankruptcy in February 2023 following a tumultuous few years of legal and financial issues—including facing FDA violations in 2019, filing for Chapter 11 bankruptcy in 2020, and selling seven of its brand ophthalmic products to Théa Pharma, Inc. in 2022.
See here for more details.
Why issue a voluntary recall?
The recall is due to the company’s closures and discontinuation of FDA-required Quality program activities—also known as current good manufacturing practices (CGMPs)—on its marketed products,
Essentially, this means that Akorn is no longer able to ensure such products meet the necessary specifications according to their labeled shelf life, leaving the potential for patient risk.
So which drugs are they recalling?
More than 70 products that were distributed across the country to various wholesalers, retailers, manufacturers, medical facilities, repackagers, and to consumers via the Internet.
See here and here for the complete lists.
What should I do if I have any of the recalled products?
Akorn is requesting for all of the affected products to be destroyed; any consumers, distributors, or retailers currently in possession of the products should discard and contact their doctor.
For any questions regarding the recall, consumers can contact the company at (800) 932-5676.
What else to know?
Théa Pharma issued a response to the recall in regards to the seven products the company acquired from Akorn last year.
According to the company, “These [seven] Théa products are not impacted by Akorn's recall. None of these products are manufactured at Akorn's U.S. facilities that have been closed.”
These products include the following:
- Akten (lidocaine hydrochloride ophthalmic gel) 3.5%
- AzaSite (azithromycin ophthalmic solution) 1% sterile ophthalmic drops
- Betimol (timolol ophthalmic solution) 0.25%. 0.5%
- Cosopt (dorzolamide hydrochloride-timolol maleate ophthalmic solution)
- Cosopt PF (dorzolamide hydrochloride-timolol maleate ophthalmic solution)
- Zioptan (tafluprost ophthalmic solution) 0.0015%