Medical Directors Consider Akorn’s Voluntary Drug Recall

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By James Augustine, MD; and Clayton Kazan, MD

On February 23, 2023, a United States drugmaker, Akorn Operating Company, abruptly closed its doors and filed for Chapter 7 bankruptcy. The company ceased all operations and laid off all of its employees in the U.S. Approximately a week later, the company announced a voluntary recall of its drugs. Here is the corporate language released by the FDA:

The Akorn Trustee initiated and announced a voluntary recall of various human and animal products by the deadline following the closure and quality business disruption of these marketed products. Interruption of the quality program means that the company will not be able to support or guarantee that the products meet all expected specifications through the shelf life stated on the label. Further distribution or use of any remaining products on the market should cease immediately. Akorn requests the destruction of all recalled products. This recall is being conducted with the knowledge of the United States Food and Drug Administration.

Several of Akorn’s drug distributors for US Industry EMS notified their customers of the recall on or around May 11.

What does the Akorn EMS drug recall mean?

Akorn has limited ability to support any future quality issues that may arise during the shelf life of its medications, so it has issued a voluntary recall. There are no specific risks for patients and there are currently no reports of adverse events related to the products that have been recalled. Akorn has manufactured and sold a few products (including adenosine injectables) that are Not be recalled and are monitored under a separate quality programme.

The FDA announcement includes a link to the list of human products included in this recall. EMS suppliers would recognize some of the products made by Akorn, including:

  • Albuterol
  • Levalbuterol
  • Fentanyl
  • Injectable naloxone
  • Injectable hydromorphone
  • Injectable midazolam
  • Injectable lorazepam
  • Proparacaine eye drops
  • Prednisolone oral solution
  • Lidocaine ointment and jelly and solution

Many of these drugs are in short supply, with no alternative source of the drug from other drug manufacturers.

As of now, there is no further clarification on the issue of the recall from the FDA. There are apparently no plans to provide further guidance.

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It already happened?

There were voluntary drug recalls prior to Akorn’s recall, but due to product contamination and labeling issues. None of these were for drugs used in EMS. This is the first recall that is the result of an unexpected company closure and unrelated to a known quality or labeling issue. Since this is the first recall of its kind, there is no credit for purchased drugs and no replacement products to purchase for recalled products.

What is an EMS leader to do?

The concern is that EMS leaders will see a recall notice and immediately withdraw important medications needed for patient care.

These are important drugs. Our view as Medical Directors is that the recall is not mandatory and does not affect the safety and efficacy of the drugs that have been purchased from this company. The voluntary nature of the recall does not mandate specific actions, as there are no known defects in the products. The recall is a safety precaution on the part of the manufacturer to limit its future liability.

The recalled EMS medicines are essential medicines for patient care and are generally in short supply, so replacements can be difficult or impossible to locate. The decision to destroy the product may lead to patient care issues if an alternative drug is not available for use.

When different manufacturers start making products and selling them in the EMS market, then is the opportunity to replace the drugs covered by this recall with new ones and destroy Akorn products. This decision has budgetary implications, and there is no reimbursement plan at any level for destroyed drugs.

At present, there is no indication that other manufacturers are at risk. We will monitor FDA communications for any changes in the recall status of Akorn-manufactured drugs.

About the Authors

James Augustine, MD; and Clayton Kazan, MD, are emergency physicians and fire/EMS medical directors.

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