Three batches of epinephrine recalled due to sterility issues and particles of various materials
American Regent voluntarily recalled three lots of an epinephrine injection after receiving reports of leaking and cracked vials and detecting particles of various materials in the product.
FDA logo in Los Angeles / Patrick T. Fallon
Pharmaceutical company American Regent, Inc. announced a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) in multidose vials, reported the Food and Drug Administration.
The recall is due to the presence of particles and a lack of assurance of sterility. The company received complaints about vials with leaks and cracks, which may compromise the sterility of the medication. In addition, during its investigation, the agency identified particles of nylon, cellulose-based material, acrylic, polyethylene and glass.
The three lots included in the recall are:
- 25128L1C0, with an expiration date of August 2026.
- 25280L1C0, with an expiration date of October 2026.
- 26108L1C0, with an expiration date of July 2027.
The products were distributed nationwide.
What is the risk?
The FDA warns that intravenous administration of epinephrine containing particles can lead to serious consequences. Particles can cause blockages and clots in blood vessels, impede blood flow to vital organs and lead to complications such as pulmonary embolism, permanent organ damage or death.
They can also cause vein irritation, inflammatory reactions, worsening of preexisting infections and allergic reactions. Furthermore, cracks in the vials may compromise the integrity of the packaging and lead to a loss of sterility and potential contamination.
As of the time of this notice, American Regent had not received any reports of adverse events related to this recall.
What should facilities that have these products do?
The company stated that distributors, retailers and healthcare facilities in possession of any of the affected products should stop using them and return them to the place of purchase or dispose of them.
The FDA also notes that patients using the recalled product should stop using it and contact their doctor or healthcare provider.
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