FDA Drug recall D-0558-2023
Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK…
- FDA Drug
- Class II
- terminated
- Published 2023-05-10
On 2023-05-10 the FDA classified a Class II recall of Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK… by Pd Rx Pharmaceuticals, citing CGMP deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0558-2023 |
| 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, 10 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 43063-0727-30) b) 90 count-bottle (NDC 43063-0727-90)
Reason
CGMP deviations.
Identifiers
| code_info | Lots: a) K22E32 Exp. 10/31/23; b) H22C33 Exp. 09/30/23; H22C81, J22C83, K22E36 Exp. 10/31/23 |
|---|
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-0558-2023%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.