Product: Losartan Potassium, 50 mg tablets, 1000 count bottle, NDC 60429-317-10
Reason for recall: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Recall initiated: 20190614
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated