FDA Drug recall D-0485-2023
Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61919-0446-90, Packag…
- FDA Drug
- Class II
- terminated
- Published 2023-04-05
On 2023-04-05 the FDA classified a Class II recall of Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61919-0446-90, Packag… by Direct Rx, citing cGMP deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0485-2023 |
| 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, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61919-0446-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Reason
cGMP deviations
Identifiers
| code_info | a) [30-count bottles] Lot, expiry: 09JA2312 , exp 2/28/2025; b) [90-count bottles] Lot, expiry: 22OC2111, exp 1/31/202…a) [30-count bottles] Lot, expiry: 09JA2312 , exp 2/28/2025; b) [90-count bottles] Lot, expiry: 22OC2111, exp 1/31/2023; 13OC2120, exp 3/31/2023; 16JY2104, exp 12/31/2023; 09AU2125 , exp 1/31/2024 ; 28JY2125 , exp 1/31/2024 ; 23SE2115 , exp 3/31/2024 ; 23SE2115 , exp 3/31/2024 ; 07JA2211 , exp 5/31/2024 ; 27JA2214 , exp 5/31/2024 ; 15AP2224 , exp 6/30/2024 ; 24MA2221 , exp 6/30/2024 ; 16AU2214 , exp 6/30/2024 . |
|---|
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-0485-2023%22
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