FDA Drug recall D-0520-2023
Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7971-3
- FDA Drug
- Class II
- ongoing
- Published 2023-04-12
On 2023-04-12 the FDA classified a Class II recall of Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7971-3 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-0520-2023 |
| 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
Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7971-3
Reason
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Identifiers
| code_info | Lot: A1723C, Exp 8/31/2025; Lot: A1922B, Exp 6/30/2024; Lot: D0622M and Lot: F2922I, Exp 7/31/2024; Lot: G3021L, Exp 1/…Lot: A1723C, Exp 8/31/2025; Lot: A1922B, Exp 6/30/2024; Lot: D0622M and Lot: F2922I, Exp 7/31/2024; Lot: G3021L, Exp 1/31/2024; Lot:H2622P & Lot: J0722C, Exp 10/31/2024. |
|---|
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-0520-2023%22
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