Recall of Vancomycin Injection Due to Glass Particulates
Eugia US LLC has initiated a voluntary nationwide recall of a specific lot of Vancomycin Hydrochloride for Injection USP, 1.25g per vial, down to the hospital and healthcare facility level. The action follows the discovery of particulate matter inside the vial, identified as glass particles.
The affected product, distributed nationwide in the United States, poses significant health risks. Administration of a product containing glass particulates can lead to blood vessel blockage, pulmonary embolisms, permanent organ damage, or death, as well as local vein irritation, inflammation, and allergic reactions. No adverse events related to this recall have been reported to date.
Healthcare facilities and providers possessing the recalled lot are advised to immediately discontinue use, quarantine the stock, and arrange for its return. Distributors and customers are being notified through recall letters, and patients experiencing related issues are advised to consult their healthcare provider.
Key points
- Recalled product: Vancomycin Hydrochloride for Injection USP, 1.25g/Vial-30mL single-dose vial.
- Affected lot number: 3VM26026A with expiration date July 2028 and NDC 55150-471-01.
- Reason for recall: Presence of particulate matter identified as glass inside the vial.
- Potential risks include blood vessel blockage, pulmonary embolism, organ damage, vein irritation, and allergic reactions.
What it means for you
Clinicians and pharmacists should note that this US FDA safety alert involves a specific foreign recall due to glass particulate contamination. Since this is an international regulatory action, healthcare professionals in Pakistan should check with the Drug Regulatory Authority of Pakistan (DRAP) and local suppliers regarding the availability and safety status of vancomycin products marketed locally. Always inspect parenteral medications for particulate matter prior to administration.
Eugia US LLC (f/k/a Auro Medics Pharma LLC) Issues Voluntary Nationwide Recall of Vancomycin Hydrochloride for Injection USP 1.25g/Vial-30mL (Single Dose Vial) Due to Presence of Particulate Matter
Summarised automatically from the official announcement. For educational purposes only — check the original source before making clinical decisions.