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
52,340 5mL vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Subpotent product:out of specification assay results observed during long term stability testing.
Product description
Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-dose 5 mL vial NDC 70069-141-01; 10x5 mL single dose vial per Carton NDC 70069-141-10.
Code / lot info
Lot#: A240438, Exp Date 1/31/26, A250125, Exp Date 8/31/26
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →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.