Drug firm Torrent Pharmaceuticals is expanding its voluntary recall for tablets used to control hypertension in the US due to detection of traces of N-Methylnitrosobutyric acid, according to health regulator US FDA.
The company is expanding recall for Losartan potassium tablets USP and Losartan potassium / hydrochlorothiazide tablets to the consumer level due to the detection of trace amounts of an unexpected impurity while testing some finished product batches manufactured utilising active pharmaceutical ingredient manufactured by Hetero Labs, Torrent Pharmaceuticals said in an announcement posted on the website of US FDA.
“The recall is expanded to include an additional three lots of Losartan potassium tablets USP and 2 lots of Losartan potassium/hydrochlorothiazide tablets, USP,” it added.
The impurity detected is N-Methylnitrosobutyric acid (NMBA), the statement said.
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, it added.
According to the regulator, the impurity is a known animal and potential human carcinogen.
“Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. Losartan Potassium and Hydrochlorothiazide tablets, USP is used to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy,” it added.