Product: Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per bottle, Rx Only,  Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920.  NDC:  13668-116-90
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