← FDA ENFORCEMENT
D-0237-2026Class III

SOMERSET THERAPEUTICS LLC

Recalling firm
SOMERSET THERAPEUTICS LLC
Product type
Drug
Status
Ongoing
Report date
2025-12-24
Distribution
Nationwide in the USA
Firm state
NJ
Product quantity
28,660 20mL vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Subpotent product:out of specification assay results observed during long term stability testing.

Product description

Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial NDC 70069-151-01; 10 x 20 Single dose vials per Carton, NDC 70069-151-10.

Code / lot info

Lot #: A250020, Exp Date 06/30/2026

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.