Product: Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg,  a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (NDC: 13668-116-10) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India.  For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ
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.
Recall initiated: 20190228
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated