FDA Drug recall D-0484-2023
Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Package…
- FDA Drug
- Class II
- terminated
- Published 2023-04-05
On 2023-04-05 the FDA classified a Class II recall of Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Package… by Direct Rx, citing cGMP deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0484-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-03-13 |
| Published | 2023-04-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Direct Rx |
| Distribution | US |
Product
Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Reason
cGMP deviations
Identifiers
| code_info | a) [30-count bottles] Lot, expiry: 05AU2206, exp 10/31/23; b) [90-count bottles] Lot, expiry: 30MA2213, exp 6/30/23; 1…a) [30-count bottles] Lot, expiry: 05AU2206, exp 10/31/23; b) [90-count bottles] Lot, expiry: 30MA2213, exp 6/30/23; 10DE2124, exp 3/31/23; 15MA2224, exp 5/32/23; 27JA2229, exp 3/31/23. |
|---|
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-0484-2023%22
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