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Losartan potassium and hydrochlorothiazide tablets, USP is used to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy. Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients.

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To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall. Torrent is only recalling lots of losartan-containing products that contain N-Methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels released by the FDA. The impurity detected in the API is N-Methylnitrosobutyric acid (NMBA). The Recall is expanded to include an additional 36 lots of Losartan potassium Tablets USP and 68 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

Losartan potassium tablets, USP Losartan potassium and Hydrochlorothiazide tablets, USP