Drug 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
D-0499-2024
Product summary
- Event
- Event 94486
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 14,360 vials
- Official record key
drug-enforcement:D-0499-2024
Official wording
Reason: Presence of Particulate Matter: Potential for black particulates in the drug product.
Code information: Lots 5100186, 5100187, 5100188, 5100189, Exp 01/31/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter