A U.S. drugmaker has recalled three lots of epinephrine injections after reports of leaking and cracked vials prompted concerns about product sterility, according to an alert from the Food and Drug Administration.
American Regent, Inc. said intravenous administration of its USP 30 mg/30 mL injections may contain particulate matter such as nylon, cellulose, acrylic, polyethylene and glass. Intravenous administration of the product could lead to serious health consequences, the alert stated.
Particulate matter can cause blockage and clotting in blood vessels, which can cut off blood flow to vital organs and lead to a life-threatening blood clot in the lungs. Additionally, cracked vials can compromise the container’s integrity, increasing the risk of contamination.
Epinephrine is used for emergency treatment of severe allergic reactions, including anaphylaxis.
The medication is supplied in multi-dose vials and may be administered intravenously, intramuscularly, or subcutaneously under the supervision or direction of a physician. American Regent said it has not received any reports of adverse events related to this recall.
Information about the affected lots is listed below:
NDCLotExpirationDistribution BeganDistribution Ended0517-3030-0125128L1C0August 2026Sept. 4, 2025Dec. 18, 202525280L1C0October 2026Dec. 16, 2025April 17, 202626108L1C0July 2027June 15, 2026July 31, 2026Hence then, the article about drugmaker recalls life saving allergy medication over sterility concerns was published today ( ) and is available on NBC Chicago ( Middle East ) The editorial team at PressBee has edited and verified it, and it may have been modified, fully republished, or quoted. You can read and follow the updates of this news or article from its original source.
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