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FDADecember 20, 2018drug

LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-count bottle (NDC: 13668-116-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

What to do

FDA enforcement status: Ongoing

Brands named

torrent pharmatorrent

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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