Drug Recall: 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 d
SOMERSET THERAPEUTICS LLC · November 26, 2025
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.
Distribution
Nationwide in the USA
States Affected
NATIONWIDE
Quantity Affected
28,660 20mL vials
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0237-2026
Status: ongoing
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