Product: Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 Rx only GSMS Incorporated
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 at the manufacturer
Recall initiated: 20190501
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated