FDA Drug recall D-0559-2023
Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm
- FDA Drug
- Class II
- terminated
- Published 2023-05-10
On 2023-05-10 the FDA classified a Class II recall of Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm by Pd Rx Pharmaceuticals, citing CGMP deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0559-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-04-06 |
| Published | 2023-05-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pd Rx Pharmaceuticals |
| Distribution | US |
Product
Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0587-90
Reason
CGMP deviations.
Identifiers
| code_info | Lots: A22B45 Exp. 01/31/24; C22A73, E22E41, C22D28, F22B68, G22A29, H22B97, K22A36 Exp. 03/31/24; K22B99, A23D07, B23B25 Exp. 10/31/24; B23B55 Exp. 06/30/25 |
|---|
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-0559-2023%22
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