Recall D-0237-2026

US Class III Ongoing · initiated 2025-11-26

Recalling firm

SOMERSET THERAPEUTICS LLC, NJ

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.

Reason for recall

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

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