SOMERSET THERAPEUTICS LLC recalls Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactur
Recalled December 24, 2025 · FDA recall D-0237-2026 · SOMERSET THERAPEUTICS
Hazard
Subpotent product:out of specification assay results observed during long term stability testing. · FDA Class III
Units
28,660 20mL vials
Sold at
Nationwide in the USA
Description
Subpotent product:out of specification assay results observed during long term stability testing.
Product
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.
Manufacturer(s)
SOMERSET THERAPEUTICS LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →