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
Subpotent product:out of specification assay results observed during long term stability testing.
Classification
Class III
Status
Ongoing
Lot
Lot#: A240438, Exp Date 1/31/26, A250125, Exp Date 8/31/26
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
SOMERSET THERAPEUTICS LLC — Class III Recall | MedicineWatch US