FDA Drug recall D-1088-2023
Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown…
- FDA Drug
- Class II
- terminated
- Published 2023-08-30
On 2023-08-30 the FDA classified a Class II recall of Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown… by Aurobindo Pharma Usa, citing cGMP deviations: Batch was released prior to approval.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1088-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-07-21 |
| Published | 2023-08-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aurobindo Pharma Usa |
| Distribution | US |
Product
Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-617-08
Reason
cGMP deviations: Batch was released prior to approval.
Identifiers
| ndc | 59651-616-08 |
|---|---|
| ndc | 59651-617-08 |
| code_info | Lot #: RB4023002A, Exp 02/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1088-2023%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.