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Recall Observatory FDA recall evidence

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)

D-0354-2025

March 21, 2025

Class II

Product summary

Firm
Somerset Therapeutics Private Limited
Event
Event 96569
Status
Ongoing
Classification
Class II
Quantity
506,080 vials
Official record key
drug-enforcement:D-0354-2025

Official wording

Reason: Lack of Assurance of Sterility: Media fill with bacterial contamination

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

Distribution pattern: U.S. Nationwide

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    bacterial contamination
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility