The impurity is N-Methylnitrosobutyric acid. Torrent is recalling only lots of losartan NMBA above the acceptable daily intake levels released by the FDA.
Losartan belongs to a class of medicines used for treating high blood pressure called angiotensin II receptor blockers. Some generic versions of other ARBs, such as valsartan and irbesartan, have also been recalled.
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 are used to treat hypertension and hypertensive patients with left ventricular hypertrophy.
Since July 2018, the FDA has announced voluntary recalls of blood pressure and heart medications from Major Pharmaceuticals, Solco Healthcare, Teva Pharmaceuticals Industries, Mylan Pharmaceuticals, Prinston Pharmaceuticals, Macleods Pharmaceuticals Limited, Camber Pharmaceuticals and Torrent.
To alleviate shortages caused by these recalls, the FDA in March approved a generic form of the blood pressure medication Diovan, or valsartan.
If you were prescribed the medications above, the Food and Drug Administration recommends you continue taking them until an alternative treatment is in place, because, "The risk of harm to the patient's health may be higher if the treatment is stopped immediately."
A list of specific recalled items is at FDA.gov. Consumers with medical questions regarding this recall or to report an adverse event can contact Torrent Pharmaceuticals Limited at 1-800-912-9561 from 8:00 am - 5:00 pm Eastern Time and Medinfo.Torrent@apcerls.com.
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