FDA Drug recall D-0499-2024
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…
- FDA Drug
- Class II
- ongoing
- Published 2024-05-22
On 2024-05-22 the FDA classified a Class II recall of 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… by Sagent Pharmaceuticals, citing presence of Particulate Matter: Potential for black particulates in the drug product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0499-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-25 |
| Published | 2024-05-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sagent Pharmaceuticals |
| Distribution | US |
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.
Identifiers
| ndc | 25021-820-05 |
|---|---|
| ndc | 25021-820-10 |
| ndc | 25021-821-05 |
| code_info | Lots 5100186, 5100187, 5100188, 5100189, Exp 01/31/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0499-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.