Multi event Drug Recall Enforcement Report Class II voluntary initiated by Ascend Laboratories LLC, originally initiated on 01-22-2021 for the product Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68 The product was recalled due to cgmp deviations: individual unidentified impurities results of the product was found at higher side of the specification limit.. 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-0264-2021 | 01-22-2021 | 02-24-2021 | Class II | 23,436 200 mL bottles | Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68 | CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit. | Terminated |
| D-0263-2021 | 01-22-2021 | 02-24-2021 | Class II | 14,205 100 mL bottles | Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88 | CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit. | Terminated |
Recalled Products
