FDA-Drug2019-03-27Class II

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.

Preferred Pharmaceuticals, Inc
Hazard

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.

Sold states
California, Georgia, Indiana
Affected count
530
Manufactured in
1250 N Lakeview Ave Ste O, N/A, Anaheim, CA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1051-2019

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