Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufact...
FDA Recall #D-0354-2025 — Class II — March 21, 2025
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)
Reason for Recall
Lack of Assurance of Sterility: Media fill with bacterial contamination
Recalling Firm
Somerset Therapeutics Private Limited — Bengaluru, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
506,080 vials
Distribution
U.S. Nationwide
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated