FDA Drug recall D-0394-2023
Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC 3 16729 00201 1
- FDA Drug
- Class II
- terminated
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class II recall of Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC 3 16729 00201 1 by Accord Healthcare, citing CGMP Deviations: recalling drug products following an FDA inspection.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0394-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-02-07 |
| Published | 2023-03-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Accord Healthcare |
| Distribution | PR |
Product
Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC 3 16729 00201 1; b) 500 Tablets NDC 16729-002-16 UPC 3 16729 00216 5; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Identifiers
| upc | 316729002011 |
|---|---|
| upc | 316729002165 |
| ndc | 16729-001-01 |
| ndc | 16729-001-16 |
| ndc | 16729-001-17 |
| ndc | 16729-002-01 |
| ndc | 16729-002-16 |
| ndc | 16729-002-17 |
| ndc | 16729-003-01 |
| ndc | 16729-003-16 |
| ndc | 16729-003-17 |
| code_info | Batches: a) R2000184, Exp. Date 4/30/2023, R2000183 Exp. Date 4/30/2023, P2002969 Exp. Date 5/31/2023, P2002970 Exp. Da…Batches: a) R2000184, Exp. Date 4/30/2023, R2000183 Exp. Date 4/30/2023, P2002969 Exp. Date 5/31/2023, P2002970 Exp. Date 5/31/2023, P2005346 Exp. Date 8/31/2023, P2005847 Exp. Date 10/31/2023, P2006133 Exp. Date 10/31/2023, P2100682 Exp. Date 1/31/2024, P2102065 Exp. Date 3/31/2024, P2102067 Exp. Date 3/31/2024, P2102068 Exp. Date 3/31/2024, P2102070 Exp. Date 3/31/2024, R2100659 Exp. Date 5/31/2024, R2100660 Exp. Date 5/31/2024, P2103898 Exp. Date 6/30/2024, P2106000 Exp. Date 7/31/2024, R2101442 Exp. Date 9/30/2024, P2201160 Exp. Date 1/31/2025, P2200695 Exp. Date 1/31/2025, P2200694 Exp. Date 1/31/2025; b) P2005530, Exp. Date 9/30/2023, P2005531 Exp. Date 9/30/2023, P2005532 Exp. Date 9/30/2023, P2005533 Exp. Date 9/30/2023, P2005846 Exp. Date 10/31/2023, P2006594 Exp. Date 11/30/2023, P2100602 Exp. Date 1/31/2024, P2100603 Exp. Date 1/31/2024, P2100604 Exp. Date 1/31/2024, P2100605 Exp. Date 1/31/2024, P2101571 Exp. Date 2/29/2024, P2101572 Exp. Date 2/29/2024, P2102046 Exp. Date |
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-0394-2023%22
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