Product: Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL Multiple-dose vial, NDC 70069-161-01; 10x10mL Multiple-dose vials per Carton, NDC 70069-161-01.
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