Multi event Drug Recall Enforcement Report Class II voluntary initiated by Amerisource Health Services LLC, originally initiated on 03-17-2023 for the product Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 68001-178-03 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. For BluePoint Laboratories The product was recalled due to cgmp deviations: recalling drug products following an fda inspection.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0758-2023 | 03-17-2023 | 05-31-2023 | Class II | 105,361 bottles | Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 68001-178-03 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. For BluePoint Laboratories | CGMP Deviations: recalling drug products following an FDA inspection. | Terminated |
| D-0759-2023 | 03-17-2023 | 05-31-2023 | Class II | 129,849 bottles | Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories | CGMP Deviations: recalling drug products following an FDA inspection. | Terminated |
| D-0757-2023 | 03-17-2023 | 05-31-2023 | Class II | 63,335 bottles | Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-177-03; Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories | CGMP Deviations: recalling drug products following an FDA inspection. | Terminated |
Recalled Products
