Torrent Pharma Inc. recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-count (NDC: 13668-117-90), b) 1000-count (N

Recalled May 8, 2019 · FDA recall D-1268-2019 · 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

54,084 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 and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-count (NDC: 13668-117-90), b) 1000-count (NDC: 13668-117-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India

Manufacturer(s)

Torrent Pharma Inc.

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