GLIMEPIRIDE Recall D-0393-2023
Description: Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-001-01 UPC 3 16729 00101 4; b) 500-count bottle NDC 16729-001-16 UPC 3 16729 00116 8; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
GLIMEPIRIDE Recall D-0393-2023 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0393-2023 |
Event ID | 91657 |
Brand | GLIMEPIRIDE |
Generic Name | GLIMEPIRIDE |
Manufacturer | GLIMEPIRIDE |
Original Package? | 1 |
Active Substance | GLIMEPIRIDE |
Drug Route | ORAL |
Distribution | United States including Puerto Rico and Canada |
Quantity | 469,944 bottles |
Recall Reason | CGMP Deviations: recalling drug products following an FDA inspection. |
Drug Classification | Class II |
Drug Code Info | 20230308 |
Product NDC | 16729-001 16729-002 16729-003 |
Product NUI | N0000175608 M0020795 |
Drug UPC | 316729001014 316729001168 |
Pharma Class (EPC) | Sulfonylurea [EPC] |
Pharma Class (CS) | Sulfonylurea Compounds [CS] |
Recall Initiation Date | 20230207 |
Report Date | 20230308 |
Classification Date | 20230302 |
Address | 1009 Slater Rd Ste 210B Durham, NC 27703-8446 United States |
Recalling Firm | Accord Healthcare, Inc. |
Initial Notification | Letter |
Unique Ingredient Identifier | 6KY687524K |
Drug Application Number | ANDA078181 |
Structured Product Labeling (SPL ID) | 8831579e-9150-f6f8-e053-2a95a90a3766 |
Structured Product Labeling (SPL Set ID) | 9b74fbac-9e04-4927-9981-1e3dace89c6d |
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