Torrent Pharma Inc. recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC:
Recalled May 8, 2019 · FDA recall D-1267-2019 · 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
331,764 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, 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (NDC: 13668-116-10), 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 →