FDA Drug recall D-0502-2023
Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx only, Repac…
- FDA Drug
- Class II
- terminated
- Published 2023-04-12
On 2023-04-12 the FDA classified a Class II recall of Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx only, Repac… by Remedyrepack, citing cGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0502-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-03-20 |
| Published | 2023-04-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Remedyrepack |
| Distribution | US |
Product
Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
Reason
cGMP Deviations
Identifiers
| code_info | Lot # a): B2038806-123022, B2014185-121422, B1925528-102522, Exp. Date 07/31/2025. Lot #: b): B2080829-012823, B1938007…Lot # a): B2038806-123022, B2014185-121422, B1925528-102522, Exp. Date 07/31/2025. Lot #: b): B2080829-012823, B1938007-110222, B2038746-123022, Exp. Date 07/31/2025. |
|---|
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-0502-2023%22
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