Drug product
Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-101-25 (immediate carton) and 70069-101-05 (5x10 mL carton)
D-0354-2025
Product summary
- Event
- Event 96569
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 506,080 vials
- Official record key
drug-enforcement:D-0354-2025
Official wording
Reason: Lack of Assurance of Sterility: Media fill with bacterial contamination
Code information: NDC 70069-101-25; A240304, A240305, A240320, A240322, A240334, A240335, A240340, exp. date 05/2026; A240342, A240347, A240385, A240391, exp. date 06/2026; NDC 70069-101-05; A240326, exp. date 05/2026
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Microbial contamination
bacterial contamination
-
Sterility assurance
Lack of Assurance of Sterility