UKM Elisabeth Deiters-Keul / Wikimedia Commons / CC BY-SA 3.0
EAST WINDSOR, N.J. – Eugia US LLC is recalling one lot of vancomycin hydrochloride for injection nationwide after a glass particle was found inside a vial, according to a company notice listed by the Food and Drug Administration.
The recall applies to lot 3VM26026A of the 1.25-gram product in 30-milliliter single-dose vials, with an expiration date of JUL 2028. It does not cover all vancomycin products.
Eugia, based in East Windsor and formerly known as Auro Medics Pharma LLC, announced the voluntary recall on November 6. The FDA’s drug-recall listing carries a November 9 posting date. The affected lot was shipped to wholesalers nationwide from September 2 through September 15, 2026.
The vial label carries National Drug Code 55150-471-01; the carton carries 55150-471-10. The recall extends to the hospital, healthcare facility and user level.
In its recall notice, Eugia warned that glass particles in an injected product can cause blood-vessel blockage and clotting, a pulmonary embolism, permanent organ damage or death. The notice also lists possible local vein irritation, inflammatory reactions, worsening of existing infections and allergic reactions. Neonates, infants and patients with compromised organ function may be more susceptible.
Those are stated risks, not reported outcomes from this recall. Eugia said in the November 6 announcement that it had received no reports of adverse events related to the recall.
The company told wholesalers, hospitals, pharmacies, institutions and doctors holding the affected lot to stop using it and quarantine it immediately. Facilities that redistributed the lot should notify receiving accounts and locations. Eugia is arranging returns or replacements.
Vancomycin hydrochloride for injection is an antibacterial used to treat certain serious infections in adults and children. Consumers who have experienced problems that may be related to this product should contact their physician or healthcare provider, the notice says.
For medical questions or adverse-event reports, Eugia lists 1-866-850-2876, option 2, Monday through Friday, 8 a.m. to 5 p.m. Eastern time. Questions about returns can go to Qualanex at 1-800-505-9291, Monday through Friday, 7 a.m. to 4 p.m. Central time.
JBizNews Desk | Health
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