← FDA ENFORCEMENT
D-0238-2026Class 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
71,310 10mL 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, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL Multiple-dose vial, NDC 70069-161-01; 10x10mL Multiple-dose vials per Carton, NDC 70069-161-01.

Code / lot info

Lot#: A250043, 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.