Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.
Reason
Failed Impurities/Degradation Specifications
Classification
Class III
Status
Ongoing
Lot
Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
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.
Sagent Pharmaceuticals — Class III Recall | MedicineWatch US