Product: Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for:  Torrent Pharma Inc., Basking Ridge, NJ 07920.  NDC 90 tablets: 13668-115-90; NDC 1000 tablets: 13668-115-10
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 of 9.82 parts per million.
Recall initiated: 20190919
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated