A New Jersey-based pharmaceutical company is recalling one lot of an antibacterial intravenous injection due to the presence of particulate matter identified as a glass particle inside the vial.
Eugia U.S. LLC said in a Nov. 6 announcement that it was recalling Vancomycin Hydrochloride for Injection USP 1.25g/Vial-30mL (Single Dose Vial), lot number 3VM26026A, which has a July 2028 expiry date. The Food and Drug Administration (FDA) posted the announcement on Monday. The product was shipped to wholesalers across the United States between Sept. 2 and 15.
The recall was voluntary and extended to the hospital, healthcare facility, and user level. The vial label carries National Drug Code 55150-471-01, and the carton carries 55150-471-10.
Vancomycin Hydrochloride is an antibacterial IV injection used to treat conditions such as skin infections, bone infections, lower respiratory tract infections, and septicemia, a bloodstream infection.
The company said there is a “reasonable probability” that using product containing glass particulates could cause serious harm, including blocked or clotted blood vessels, a life-threatening blood clot in the lungs known as pulmonary embolism, permanent organ damage, or death.
The particles may also cause vein irritation, inflammation, worsening of existing infections, and allergic reactions, the company said. It said neonates, infants, and patients with compromised organ function may be more susceptible. A neonate is a newborn.
Eugia said it had received no reports of adverse events related to the recall. The announcement didn’t say how the particle got into the vial.
The company advised wholesalers, hospitals, pharmacies, institutions, and doctors with the lot to stop using it and quarantine it immediately. It said it was notifying distributors and customers by letter and arranging returns or replacements.
Consumers who have experienced problems that may be related to the drug should contact their physician or healthcare provider, the company said. Questions or adverse events can be reported to Eugia at 1-866-850-2876. Adverse reactions can also be reported to the FDA’s MedWatch program.
The Epoch Times reached out to Eugia for comment but did not receive a response by publication time.
Glass particles can appear in a medicine vial due to mechanical or chemical causes, according to a December 2025 post by London-based pharmaceutical consulting firm Inglasia.
One mechanical cause is glass-to-glass contact, in which vials moving along production lines slide against or hit each other, causing friction damage and chipping, the post said. Another is flaws from the vial manufacturing process.
A chemical cause is delamination, in which the inner glass surface flakes off because of a chemical interaction between the drug and the container, the post said.
An analysis of FDA recall data by consultants at ELIQUENT Life Sciences, published in the Parenteral Drug Association’s PDA Letter, counted about 305 foreign-matter recalls among roughly 5,578 sterile injectable drug recalls from June 2012 through March 2026.
The authors said 13 glass-particle recalls were attributed to delamination. They wrote that buying high-quality glass and maintaining strong operational controls can reduce such recalls.
Separately, the FDA issued a warning letter Aug. 13 to Eugia Pharma Specialities Ltd. and copied Eugia U.S. LLC on it as the company’s U.S. agent. The letter cited violations of current good manufacturing practice at a sterile injectable drug facility in Kolthur Village, India, including the design of its sterile-manufacturing lines, operators’ technique, and contamination monitoring. It didn’t mention glass particles.
The recall announcement didn’t say where the recalled lot was made.
