Akorn Operating Company Announces Voluntary Recall of Medications: How Should EMS Respond?

On February 23, 2023, a United States drugmaker named Akorn Operating Company closed its doors abruptly and filed Chapter 7 bankruptcy. The company ceased all operations and terminated all its employees in the US. About a week later, the company announced a voluntary recall of its medications.

“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,” states the FDA notice. “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 the destruction of any recalled products. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.”

The link to the FDA notice is here. At the bottom of that announcement is the link to the list of human products that are included in this recall. Many of the distributors of Akorn medicines to the US EMS industry notified their customers around May 11.

What does this mean?

Akorn has limited capacity to support any future quality concerns that may arise during the shelf life of its medications, so it 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.

Has this happened before?

There has 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. And in this being the first recall of this kind, there is no credit for drugs purchased, and no product to purchase in place of the recalled products.

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 solution

Many of these medications are in very short supply, with no alternate source of the medication from other drugmakers. And as of now, there is no further clarification on the recall issue from the FDA. There are no plans to provide further guidance.

What does this mean for EMS providers?

The concern is that EMS leaders will see recall notices and immediately pull important medications needed for patient care.

These are important medications. The perspective of these 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.

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 present, 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.