Class III Recall

SOMERSET THERAPEUTICS LLC

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
Subpotent product:out of specification assay results observed during long term stability testing.
Classification
Class III
Status
Ongoing
Lot
Lot #: A250020, Exp Date 06/30/2026
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