PharmacovigilanceOfficial

Eugia recalls vancomycin 1.25g vial lot in US after glass particle found

🇺🇸 FDA MedWatch · Mon 09 Nov 2026

Eugia US is recalling one lot of vancomycin for injection to hospital level after a glass particle was identified inside a vial; no adverse events have been reported.

Eugia US LLC, formerly Auro Medics Pharma LLC, has voluntarily recalled lot 3VM26026A of Vancomycin Hydrochloride for Injection USP 1.25g/Vial-30mL (single dose vial) across the US. The company announced the action on 6 November 2026 from East Windsor, New Jersey, and the FDA published it on 9 November. The recall extends to the hospital, healthcare facility and user level.

The reason is the presence of particulate matter, identified as a glass particle inside the vial. The company's risk statement says there is a reasonable probability that glass particulates could cause serious harm, including blockage and clotting in blood vessels, pulmonary embolism, permanent organ damage or death. It adds that local vein irritation, inflammatory reactions, aggravation of existing infections and allergic reactions are possible, and that neonates, infants and patients with compromised organ function may be more susceptible. Eugia says it has received no reports of adverse events linked to the recall.

The affected product is packed in a 30 mL vial, in cartons of 10 vials, with 10 cartons per shipper. The carton carries NDC 55150-471-10 and the vial NDC 55150-471-01, with lot number 3VM26026A and expiry July 2028. Eugia shipped the entire lot to wholesalers nationwide between 2 and 15 September 2026.

Vancomycin is a glycopeptide antibacterial indicated in adults and paediatric patients, including neonates, for septicaemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections. Eugia is notifying distributors and customers by recall letter and arranging return or replacement. Wholesalers, hospitals, pharmacies, institutions and doctors holding the lot should stop using it and quarantine it immediately, and notify any accounts they have supplied onwards.

Questions on returns go to Qualanex on 1-800-505-9291 or recall@qualanex.com. Medical questions and adverse event reports can be directed to Eugia on 1-866-850-2876 (option 2) or pvg@aurobindousa.com, and to the FDA's MedWatch programme. The company says the recall is being conducted with the knowledge of the FDA.

What it means for your team

  • Hospital pharmacies and wholesalers should check inventory for lot 3VM26026A (expiry July 2028, NDC 55150-471-01/-10) and quarantine any stock immediately.
  • Because the lot was shipped to wholesalers between 2 and 15 September 2026, firms that redistributed it should notify downstream accounts and record the actions taken.
  • Quality teams should note that a visible foreign particle, here glass, in a sterile injectable can trigger a recall even without reported adverse events.
  • Pharmacovigilance teams should route any suspected product-related events to Eugia and MedWatch, noting the heightened susceptibility cited for neonates, infants and patients with compromised organ function.

Official source: FDA MedWatch ↗

Article written by VigiEye from the official source (FDA MedWatch). AI-assisted; check the source before acting.

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