Drug Enforcement D-0354-2025

Lack of Assurance of Sterility: Media fill with bacterial contamination

Status

Ongoing

Classification

Class II

Report Date

April 16, 2025

Termination Date

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Product Information

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)
Product quantity
506,080 vials
Reason for recall
Lack of Assurance of Sterility: Media fill with bacterial contamination
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
U.S. Nationwide

Location & Firm

Recalling firm
Somerset Therapeutics Private Limited
Address
54/1 Budihal Village, N/A

India
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0354-2025
Event ID
96569
Recall initiation date
March 21, 2025
Center classification date
April 8, 2025
Code 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
More code info
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