American Regent, Inc. issued a voluntary nationwide recall of three lots of epinephrine injection multi-dose vials after identifying particulate matter and a lack of sterility assurance on Sept. 3, the Food and Drug Administration announced.
Epinephrine is a first-line emergency medication used to treat severe allergic reactions and cardiac arrest, meaning the recall directly affects some of the most critical moments in emergency medicine across hospitals, emergency rooms and EMS systems nationwide.
The presence of particulate matter in an injectable medication poses risks including blood vessel blockage, inflammation and infection, according to the FDA. A lack of sterility assurance raises additional concerns about bacterial contamination.
Hospitals and emergency departments are the primary users of the affected multi-dose vials, which differ from the single-dose auto-injectors commonly carried by consumers with severe allergies.
The recall is classified as voluntary, meaning the manufacturer initiated the action, though the FDA is overseeing the process. Healthcare providers in possession of the affected lots are advised to stop using the product and return it to the manufacturer.
Epinephrine shortages have periodically strained the U.S. healthcare system in recent years, and any disruption to supply can force hospitals to implement conservation protocols that affect patient care.
American Regent, based in New York, manufactures injectable pharmaceuticals for hospital and clinical use. The company’s announcement identified three specific lot numbers, which healthcare facilities can verify against their inventory.