Eugia pulls vancomycin lot from US supply chain after glass found in vial

Eugia US, the American arm formerly trading as Auro Medics Pharma, is retrieving one batch of vancomycin for injection from the US market after a glass particle was identified inside a vial. The company announced the action on 6 November from East Windsor, New Jersey, and the FDA posted notice on 9 November.

The commercial footprint is narrow but reaches deep. Only lot 3VM26026A of the 1.25g/30mL single-dose presentation is affected, but the entire lot went to wholesalers between 2 and 15 September 2026, so the recall extends down to hospitals, healthcare facilities and individual users. Eugia has not said how many vials or cartons the lot contained, and it has not commented on any effect on supply of the product. It says it is contacting distributors and customers by letter and arranging returns or replacements.

Eugia identifies the product by NDC 55150-471-01 for the vial and 55150-471-10 for the carton, with an expiry of July 2028. Cartons hold 10 vials, and a shipper holds 10 cartons. The company's risk statement warns that glass particulates could cause serious harm, including vessel blockage, pulmonary embolism, organ damage or death. It also lists local vein irritation, inflammatory and allergic reactions and worsening of existing infections as possible effects. Neonates, infants and patients with compromised organ function may be more susceptible. Eugia reports no adverse events tied to the lot.

Vancomycin is a long-established glycopeptide antibiotic used in adults and children, including neonates, for septicaemia, infective endocarditis, skin and bone infections and lower respiratory tract infections. Holders of the lot are being told to stop using and quarantine it and to alert any accounts they supplied. Returns are handled by Qualanex (1-800-505-9291, recall@qualanex.com), and medical queries or adverse event reports go to Eugia (1-866-850-2876, option 2; pvg@aurobindousa.com) or to MedWatch. The company says the FDA is aware of the recall.