The agency behind blood pressure medication tablets has expanded a recall for 2 merchandise after trace portions of a possible cancer-causing ingredient was detected inside the tablets.
Torrent Pharmaceuticals Limited said its Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, are affected by the recall.
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The ingredient detected was acknowledged as N-Methylnitrosobutyric acid (NMBA), a recognized animal and potential human carcinogen. The agency said the recall solely impacts merchandise found to have higher than the FDA-allowable amount of NMBA.
The agency issued an preliminary recall in December, adopted by two further in January and March. The fourth recall consists of an additional 36 a whole lot of Losartan Potassium Tablets USP and 68 a whole lot of Losartan Potassium/hydrochlorothiazide Tablets, USP.
A full guidelines of the impacted merchandise might be found proper right here.
According to the recall uncover posted on the FDA website, the company has not acquired any research of antagonistic reactions related to the recall. The medication is used to cope with hypertension, hypertensive victims with Left Ventricular Hypertrophy and nephropathy in Type 2 diabetic victims. Patients are prompt to steer clear of sudden stoppage of medication, and to hunt the recommendation of their pharmacist or physician.