Product: LOSARTAN POTASSIUM 100 mg TABLET BULK  90 count bottles, NDC 00591-3747-00
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: 20190606
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated