FDA-Drug2025-04-16Class II
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)
Somerset Therapeutics Private Limited
Hazard
Lack of Assurance of Sterility: Media fill with bacterial contamination
Sold states
U.S. Nationwide
Affected count
506,080 vials
Manufactured in
54/1 Budihal Village, N/A, Bengaluru, N/A, India
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0354-2025Don't want to check this manually?
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