Drug recall D-0499-2024
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 for recall
Presence of Particulate Matter: Potential for black particulates in the drug product.
Lots and codes
Lots 5100186, 5100187, 5100188, 5100189, Exp 01/31/2025
Recall details
- Recalling firm
- Sagent Pharmaceuticals, Schaumburg, IL
- Quantity
- 14,360 vials
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 25, 2024
Related products
- Methylprednisolone acetate – drug information
- NDC 25021-821 Methylprednisolone acetate · Methylprednisolone Acetate 80 mg/mL · Sagent Pharmaceuticals
- NDC 25021-820 Methylprednisolone acetate · Methylprednisolone Acetate 40 mg/mL · Sagent Pharmaceuticals