Product: 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.
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