FDA Drug recall D-0503-2023
Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-00), Rx only, Repack…
- FDA Drug
- Class II
- terminated
- Published 2023-04-12
On 2023-04-12 the FDA classified a Class II recall of Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-00), Rx only, Repack… by Remedyrepack, citing cGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0503-2023 |
| 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
Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
Reason
cGMP Deviations
Identifiers
| code_info | Lot # a): J0656821-103122, Exp. Date 11/30/2023; J0638547-080922, Exp. Date 08/31/2023; J0633575-071822, Exp. Date 07/3…Lot # a): J0656821-103122, Exp. Date 11/30/2023; J0638547-080922, Exp. Date 08/31/2023; J0633575-071822, Exp. Date 07/31/2023 Lot #: b): B1965081-111622, Exp. Date 03/31/2025; B1857922-091922, B1765298-071322, B1786319-072922, B1706842-053122, Exp. Date 04/30/2023; B2003311-120822, Exp. Date 04/30/2025; B1955679-111122, Exp. Date 02/28/2025; B1878942-092922, Exp. Date 11/30/2024; B1823203-082622. Exp. Date 10/31/2024; B1706843-053122, Exp. Date 05/31/2023 |
|---|
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-0503-2023%22
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