FDA Drug recall D-0525-2023
Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9)
- FDA Drug
- Class II
- ongoing
- Published 2023-04-12
On 2023-04-12 the FDA classified a Class II recall of Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9) 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-0525-2023 |
| 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, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-6); c) 30-count bottle (NDC 68788-9868-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.
Reason
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Identifiers
| code_info | a) Lot: B0922G, Exp. Date: 5/31/2023, F0322G, Exp. Date: 7/25/2024, H2622M, Exp. Date: 8/31/2024, J1422B, K0722G, Exp.…a) Lot: B0922G, Exp. Date: 5/31/2023, F0322G, Exp. Date: 7/25/2024, H2622M, Exp. Date: 8/31/2024, J1422B, K0722G, Exp. Date: 10/31/2024, L1922A, Exp. Date: 2/28/2025; b) Lot: F2922S, Exp. Date: 8/31/2023, H0322G Exp. Date: 7/31/2023; c) Lot: A1322I, Exp. Date: 3/31/2023, H1122C, Exp. Date: 8/31/2024. |
|---|
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-0525-2023%22
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