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  3. Recall Enforcement Event ID: 82706

Recall Enforment Report D-1249-2019

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by AVKARE Inc., originally initiated on 04-24-2019 for the product Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478 The product was recalled due to cgmp deviations: fda lab confirmed presence of an impurity, n-methylnitrosobutyric acid (nmba) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-1249-201904-24-201905-08-2019Class II1438 cartons (71,900 tablets)Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.Ongoing
D-1250-201904-24-201905-08-2019Class II846 cartons (42,300 tablets)Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.Ongoing