GLIMEPIRIDE Recall D-0313-2024
Description: Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-05
GLIMEPIRIDE Recall D-0313-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0313-2024 |
| Event ID | 93833 |
| Brand | GLIMEPIRIDE |
| Generic Name | GLIMEPIRIDE |
| Manufacturer | GLIMEPIRIDE |
| Original Package? | 1 |
| Active Substance | GLIMEPIRIDE |
| Drug Route | ORAL |
| Distribution | Nationwide |
| Quantity | 14,425 bottles |
| Recall Reason | Misprint on tablet |
| Drug Classification | Class III |
| Drug Code Info | 20240214 |
| Product NDC | 55111-320 55111-321 55111-322 |
| Product NUI | N0000175608 M0020795 |
| Pharma Class (EPC) | Sulfonylurea [EPC] |
| Pharma Class (CS) | Sulfonylurea Compounds [CS] |
| Recall Initiation Date | 20240118 |
| Report Date | 20240214 |
| Classification Date | 20240206 |
| Address | 107 College Rd E Princeton, NJ 08540-6623 United States |
| Recalling Firm | Dr. Reddy's Laboratories, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 6KY687524K |
| Drug Application Number | ANDA077091 |
| Structured Product Labeling (SPL ID) | e3d50334-9896-b2f9-a481-8383eb84b16a |
| Structured Product Labeling (SPL Set ID) | 07ad4366-4b21-f633-49f3-c2b35f88168d |
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