FDAHealthMarch 21, 2025
Somerset Therapeutics Private Limited — 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 7
⚠️ Lack of Assurance of Sterility: Media fill with bacterial contamination
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 21, 2025
U.S. Nationwide
What's affected?
- 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)
- Brand
- METHOCARBAMOL
- UPC
- 0370069101018
- Lot code
- 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
Additional details
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
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 506,080 vials.
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