Torrent Pharma Inc. recalls LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1000-count (NDC: 13668-113-10), per bottle,

Recalled April 17, 2019 · FDA recall D-1114-2019 · Torrent Pharma

Hazard

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. · FDA Class II

Units

133,992 bottles

Sold at

Nationwide USA and Puerto Rico

Description

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

Product

LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1000-count (NDC: 13668-113-10), 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

Manufacturer(s)

Torrent Pharma Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →