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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