Product: Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b) 90-count bottle (NDC: 68788-0048-09), Rx Only, Mfg: Torrent Pharma Inc. Basking Ridge, NJ. Relabeled by: Preferred Pharmaceuticals, Inc. 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807.
Reason for recall: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
Recall initiated: 20190306
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated