GLIMEPIRIDE Recall D-0551-2023
Description: Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b)90-count bottles (NDC 51655-383-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.
GLIMEPIRIDE Recall D-0551-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0551-2023 |
| Event ID | 91944 |
| Brand | GLIMEPIRIDE |
| Generic Name | GLIMEPIRIDE |
| Manufacturer | GLIMEPIRIDE |
| Active Substance | GLIMEPIRIDE |
| Drug Route | ORAL |
| Distribution | Nationwide with the United States |
| Quantity | a) 230 bottles; b) 22 bottles |
| Recall Reason | CGMP Deviations |
| Drug Classification | Class II |
| Drug Code Info | 20230503 |
| Product NDC | 51655-383 |
| Product NUI | N0000175608 M0020795 |
| Pharma Class (EPC) | Sulfonylurea [EPC] |
| Pharma Class (CS) | Sulfonylurea Compounds [CS] |
| Recall Initiation Date | 20230316 |
| Report Date | 20230503 |
| Classification Date | 20230426 |
| Address | 4838 Fletcher Ave Ste 1000 Indianapolis, IN 46203-1642 United States |
| Recalling Firm | Northwind Pharmaceuticals LLC |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Unique Ingredient Identifier | 6KY687524K |
| Drug Application Number | ANDA078181 |
| Structured Product Labeling (SPL ID) | f2f2d6da-eb41-4290-e053-2a95a90a6ca0 |
| Structured Product Labeling (SPL Set ID) | f2f2d6da-eb40-4290-e053-2a95a90a6ca0 |
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