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

Recall Number: D-1268-2019

Firm: Torrent Pharma Inc.

Classification: Class II

Status: Ongoing

Report Date: 20190508

Initiation Date: 20190418

Termination Date:

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

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