Recall Enforment Report D-1046-2019
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by AVKARE Inc., originally initiated on 03-05-2019 for the product Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-514-15 The product was recalled due to cgmp deviations: presence of an impurity, n-methylnitrosobutyric acid (nmba) was identified. 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-1046-2019 | 03-05-2019 | 03-27-2019 | Class II | N/A | Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-514-15 | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified | Terminated |
| D-1044-2019 | 03-05-2019 | 03-27-2019 | Class II | N/A | Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 ---- NDC 50268-517-15 | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified | Terminated |
| D-1045-2019 | 03-05-2019 | 03-27-2019 | Class II | N/A | Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-513-15 | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified | Terminated |
