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India's Torrent Pharmaceuticals recalls hypertension drugs in US, Puerto Rico

Torrent Pharmaceuticals Ltd. is voluntarily recalling 73,896 bottles of certain hypertension medications due to high levels of a potentially cancer-causing impurity, the U.S. Food and Drug Administration said.

The regulatory body said the recalls of losartan potassium and hydrochlorothiazide tablets were due to the presence of higher than accepted levels of an impurity called N-methylnitrosobutyric acid.

The action — initiated in the U.S. and Puerto Rico — is classified as a class 2 recall, which, according to the FDA, is a situation in which the use of or exposure to the drug may cause temporary or medically reversible harmful health effects or where the probability of serious adverse health consequences is remote.

Gujarat, India-based Torrent Pharmaceuticals has also twice recalled certain high blood pressure medications for the same reason.