Thought leadership on the clinical impact on workers' compensation and auto no-fault.
Several drug products voluntarily removed from the market due to manufacturer bankruptcy
The U.S. Food and Drug Administration (FDA) announced that Akorn Operating Company LLC is voluntarily recalling several drug products at the consumer level. Examples of recalled drug products include, lidocaine ointment 5%, lactulose solution 10 gm/15 ml, and fluticasone propionate nasal suspension 50 mcg/actuation. For a complete list of recalled products, click here.
Reason for medication recall
Akorn Operating Company LLC filed Chapter 7 bankruptcy and the company has ceased all operations, including the discontinuation of the quality activities of these marketed drug products. The discontinuation of the quality program means the company will not be able to support or guarantee the drug products will meet all intended specifications through the labeled shelf life of the product.
Akorn is notifying its distributors and direct customers by letter and is requesting the destruction of any recalled products. Pharmacies should not dispense these products to consumers.
Impact on workers’ compensation and auto no-fault
There has been minimal impact in our book of business. Akorn recommends consumers that have recalled drug products should discard the product and contact their prescriber. Some dispensing pharmacies may have already contacted consumers about this recall.
It is important to note there are multiple manufacturers of these drug products. Because of this, consumers will be able to obtain a replacement product from another manufacturer at their dispensing pharmacy.
For more information on this recall and contact information for Akorn, please click here.
If you have any questions, please contact your account manager, clinical liaison, or our Clinical Services team at 1-877-275-7674 ext. 8612.
1. U.S. Food and Drug Administration. Safety/Recalls, Market Withdrawals & Safety Alerts. Company Announcement: Akorn Issues Voluntary Nationwide Recall of Various Human and Animal Drug Products Within Expiry Due to Company Shutdown | FDA accessed April 28, 2023