Product: Losartan Potassium 100 mg, 30 Tabs bottles, Rx only,  Packaged and Distributed By: Direct Rx Dawsonville, GA 30534  NDC 61919-952-30
Reason for recall: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer
Recall initiated: 20190430
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated