FDA Drug recall D-0758-2023
Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00
- FDA Drug
- Class II
- terminated
- Published 2023-05-31
On 2023-05-31 the FDA classified a Class II recall of Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00 by Amerisource Health Services, citing CGMP Deviations: recalling drug products following an FDA inspection.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0758-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-03-17 |
| Published | 2023-05-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amerisource Health Services |
| Distribution | US |
Product
Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 68001-178-03 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. For BluePoint Laboratories
Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Identifiers
| code_info | Batches a)P2003493, EXP 05/31/2023; P2100120, EXP 11/30/2023; P2100683, EXP 01/31/2024; P2106002, EXP 07/31/2024; R220…Batches a)P2003493, EXP 05/31/2023; P2100120, EXP 11/30/2023; P2100683, EXP 01/31/2024; P2106002, EXP 07/31/2024; R2200148, EXP 12/31/2024; R2201125, EXP 06/30/2025 b) P2003403, EXP 05/31/2023; b) P2005800, EXP 09/30/2023; P2101156, EXP 01/31/2024; P2105401, EXP 07/31/2024; R2200083, EXP 12/31/2024; R2201004, EXP 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-0758-2023%22
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