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.
Recall initiated: 20251126
Status: Ongoing
Classification: Class III
Recall type: Voluntary: Firm initiated