Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA, Mfg: Torrent Pharma Inc., Basking Ridge, NJ

Recall Number: D-1281-2019

Firm: Preferred Pharmaceuticals, Inc

Classification: Class II

Status: Terminated

Report Date: 20190522

Initiation Date: 20190430

Termination Date: 20230403

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

Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA, Mfg: Torrent Pharma Inc., Basking Ridge, NJ