FDA recall D-0354-2025

Somerset Therapeutics Private Limited · Class II · drug

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

Distribution

U.S. Nationwide

Key facts

Status: Ongoing
Initiation date: 2025-03-21
Report date: 2025-04-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bengaluru, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0354-2025