MedicineWatch US
Class II Recall

Sagent Pharmaceuticals

Product
MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10
Reason
Presence of Particulate Matter: Potential for black particulates in the drug product.
Classification
Class II
Status
Ongoing
Lot
Lots 5100186, 5100187, 5100188, 5100189, Exp 01/31/2025
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 II Recall | MedicineWatch US