Drug recall D-0354-2025

Class II Ongoing reported Apr 16, 2025

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)

Reason for recall

Lack of Assurance of Sterility: Media fill with bacterial contamination

Lots and codes

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

Recall details

Recalling firm
Somerset Therapeutics Private Limited, Bengaluru, N/A
Quantity
506,080 vials
Distribution
U.S. Nationwide
Type
Voluntary: Firm initiated
Recall initiated
March 21, 2025

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