← FDA ENFORCEMENT
D-0354-2025Class II

Somerset Therapeutics Private Limited

Recalling firm
Somerset Therapeutics Private Limited
Product type
Drug
Status
Ongoing
Report date
2025-04-16
Distribution
U.S. Nationwide
Firm state
N/A
Product quantity
506,080 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility: Media fill with bacterial contamination

Product description

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)

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.