GLIMEPIRIDE Recall D-0527-2023
Description: Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9
GLIMEPIRIDE Recall D-0527-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0527-2023 |
| Event ID | 91952 |
| Brand | GLIMEPIRIDE |
| Generic Name | GLIMEPIRIDE |
| Manufacturer | GLIMEPIRIDE |
| Active Substance | GLIMEPIRIDE |
| Drug Route | ORAL |
| Distribution | USA Nationwide |
| Quantity | 15 Bottles |
| Recall Reason | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. |
| Drug Classification | Class II |
| Drug Code Info | 20230412 |
| Product NDC | 68788-8066 |
| Product NUI | N0000175608 M0020795 |
| Pharma Class (EPC) | Sulfonylurea [EPC] |
| Pharma Class (CS) | Sulfonylurea Compounds [CS] |
| Recall Initiation Date | 20230323 |
| Report Date | 20230412 |
| Classification Date | 20230406 |
| Address | 1250 N Lakeview Ave Ste O Anaheim, CA 92807-1801 United States |
| Recalling Firm | Preferred Pharmaceuticals, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 6KY687524K |
| Drug Application Number | ANDA078181 |
| Structured Product Labeling (SPL ID) | 9daf0202-6c94-4b42-9bc6-3e473c771b63 |
| Structured Product Labeling (SPL Set ID) | fc359d31-ef3d-4d6f-bd5a-8636f8211aea |
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