FDA Drug recall D-0519-2023
Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-7086-3)
- FDA Drug
- Class II
- ongoing
- Published 2023-04-12
On 2023-04-12 the FDA classified a Class II recall of Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-7086-3) 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-0519-2023 |
| 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, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-7086-3); b) 90-count bottle (NDC 68788-7086-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
Reason
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Identifiers
| code_info | a) Lot: F2022N, Exp. Date: 2/29/2024; b) Lot: F0322I, Exp. Date: 8/31/2023; Lot: J1322H, Exp. Date: 2/29/2024; Lot: K02…a) Lot: F2022N, Exp. Date: 2/29/2024; b) Lot: F0322I, Exp. Date: 8/31/2023; Lot: J1322H, Exp. Date: 2/29/2024; Lot: K0222N, Exp. Date: 6/30/2024; Lot: L2322D and Lot: L2822J, Exp. Date:7/31/2025. |
|---|
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-0519-2023%22
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