FDA Drug recall D-0561-2023
Simvastatin USP 40 mg, 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 Simvastatin USP 40 mg, Rx only, Intas Pharm by Pd Rx Pharmaceuticals, citing CGMP deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0561-2023 |
| 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
Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0726-30) b) 90 count-bottle (NDC 43063-0726-90)
Reason
CGMP deviations.
Identifiers
| code_info | Lots: a) A22A17, D22C21 Exp. 07/31/23; K22D89, L22B26, L22D14 Exp. 03/31/24; L22D96 Exp. 04/30/24; b) L21E06 Exp. 05/31…Lots: a) A22A17, D22C21 Exp. 07/31/23; K22D89, L22B26, L22D14 Exp. 03/31/24; L22D96 Exp. 04/30/24; b) L21E06 Exp. 05/31/23; B22C05, D22B91, E22C82 Exp. 07/31/23; G22B03 G22B79, H22A30, J22B81 Exp. 08/31/23; J22F27, K22B37, K22B88 Exp. 10/31/23; L22D32 Exp. 03/31/24; B23E07 Exp. 04/30/24 |
|---|
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-0561-2023%22
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