By James Augustine, MD; and Clayton Kazan, MD
On February 23, 2023, a United States drugmaker, the Akorn Operating Company, closed its doors abruptly and filed Chapter 7 bankruptcy. The company ceased all operations and terminated all of its employees in the U.S. About a week later, the company announced a voluntary recall of its medications. Here is the company language released by the FDA:
The Akorn Trustee initiated and announced a voluntary recall of various within-expiry human and animal products as a result of the closures and discontinuation of the Quality activities of these marketed products. 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. Further distribution or use of any remaining product on the market should cease immediately. Akorn is requesting destruction of any recalled products. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.”
Many of the distributors of Akorn medicines to the U.S. EMS industry notified their customers about the recall around May 11.
What does the Akorn drug recall mean for EMS?
Akorn has limited capacity to support any future quality concerns that may arise during the shelf life of their medications, so they issued a voluntary recall. There are no specific risks to patients, and there are currently no reports of adverse events related to the products that have been recalled. Akorn manufactured and sold a few products (including adenosine injectables) that are not being recalled, and are being monitored under a separate quality program.
The FDA announcement includes a link to the list of human products that are included in this recall. EMS providers would recognize some of the products that were produced by Akorn, including:
- Albuterol
- Levalbuterol
- Fentanyl
- Naloxone injectable
- Hydromorphone injectable
- Midazolam injectable
- Lorazepam injectable
- Proparacaine eyedrops
- Prednisolone oral solution
- Lidocaine ointment and jelly and solution
Many of these medications are in very short supply, with no alternate source of the medication from other drugmakers.
As of now, there is no further clarification on the recall issue from the FDA. There are apparently no plans to provide further guidance.
Read more:
Research analysis: Midazolam vs. morphine
Should we be using midazolam instead of morphine in congestive heart failure?
Has this happened before?
There have been voluntary medication recalls before the Akorn recall, but for product contamination and labeling problems. None of these were for medications used in EMS. This is the first recall that is a result of an abrupt company closure, and not related to a known quality or labeling problem. As this is the first recall of this kind, there is no credit for drugs purchased, and no product to purchase in place of the recalled products.
What is an EMS leader to do?
The concern is that EMS leaders will see a recall notice and immediately pull the important medications needed for patient care.
These are important medications. Our perspective as medical directors is that the recall is not mandatory, and does not relate to the safety and effectiveness of the drugs that have been purchased from this company. The voluntary nature of the recall does not mandate specific action, because there are no known defects in the products. The recall is a safety precaution by the manufacturer to limit future liability on their part.
The EMS drugs being recalled are mainstay medications for patient care, and in general are in very short supply, so replacements may be difficult or impossible to locate. The decision to destroy the product may result in patient care issues if an alternate medication is not available for use.
When different manufacturers begin to manufacture products and sell them into the EMS market, it is then the opportunity to replace the medications covered by this recall with new ones, and destroy the Akorn products. There are budget implications to that decision, and there is no reimbursement plan at any level for destroyed medications.
At the present time, there is no indication that other manufacturers are at risk. We will monitor FDA communications for any change in the recall status of medications produced by Akorn.
About the authors
James Augustine, MD; and Clayton Kazan, MD, are emergency physicians and fire/EMS medical directors.
