FDA Drug recall D-0366-2024
Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in India for: Eugia US…
- FDA Drug
- Class II
- ongoing
- Published 2024-03-13
On 2024-03-13 the FDA classified a Class II recall of Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in India for: Eugia US… by Eugia Us, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0366-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-20 |
| Published | 2024-03-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Eugia Us |
| Distribution | LA, MS, OH, TN |
Product
Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-314-01
Reason
Failed Dissolution Specifications
Identifiers
| ndc | 55150-313-25 |
|---|---|
| ndc | 55150-313-01 |
| ndc | 55150-314-25 |
| ndc | 55150-314-01 |
| code_info | Lot #: 3MA23001, 3MA23002, 3MA23003, Exp 3/31/2025 |
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-0366-2024%22
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