FDA Drug recall D-0480-2023
Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30
- FDA Drug
- Class II
- terminated
- Published 2023-04-05
On 2023-04-05 the FDA classified a Class II recall of Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30 by Direct Rx, citing cGMP deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0480-2023 |
| 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
Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Reason
cGMP deviations
Identifiers
| code_info | a) [30 count bottles] Lot, expiry: 07MA2208, exp 5/31/2024 b) [90 count bottles] Lot, expiry: 09AU2128 , exp 1/31/20…a) [30 count bottles] Lot, expiry: 07MA2208, exp 5/31/2024 b) [90 count bottles] Lot, expiry: 09AU2128 , exp 1/31/2024; 28JY2102 , exp 1/31/2024; 06AU2103 , exp 1/31/2024 ; 03JA2210 , exp 1/31/2024 ; 14JY2114 , exp 1/31/2024 ; 05NO2106 , exp 2/29/2024 ; 13OC2118 , exp 2/29/2024 ; 08DE2121 , exp 2/29/2024 ; |
|---|
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-0480-2023%22
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