FDA Drug recall D-0523-2023
Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9429-9
- FDA Drug
- Class II
- ongoing
- Published 2023-04-12
On 2023-04-12 the FDA classified a Class II recall of Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9429-9 by Preferred Pharmaceuticals, citing cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0523-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-23 |
| Published | 2023-04-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Preferred Pharmaceuticals |
| Distribution | US |
Product
Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9429-9
Reason
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Identifiers
| code_info | Lot: B0222S, Exp 2/29/2024; Lot: F1121B, G2721L, Exp 11/30/2023. |
|---|
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-0523-2023%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.