Torrent Pharmaceuticals Limited has increased its voluntary recall of losartan potassium tablets after finding trace amounts of an “unexpected impurity.”
The expanded recall contains an additional three lots of losartan potassium tablets USP and two lots of losartan potassium/hydrochlorothiazide tablets.
The impurity is N-Methylnitrosobutyric acid. Torrent is recalling solely several losartan NMBA above the appropriate everyday consumption ranges launched by the FDA.
Losartan belongs to a category of medicines used for treating hypertension known as angiotensin II receptor blockers. Some generic versions of other ARBs, similar to valsartan and irbesartan, have additionally been recalled.
Losartan is used to treat hypertension patients, hypertensive patients who left ventricular hypertrophy and used 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 medicines from Main Pharmaceuticals, Solco Healthcare, Teva Pharmaceuticals Industries, Mylan Pharmaceuticals, Prinston Pharmaceuticals, Macleods Pharmaceuticals Limited, Camber Pharmaceuticals, and Torrent.
To alleviate shortages attributable to these recalls, the FDA in March approved a generic form of the blood pressure medication Diovan, or valsartan.
In case you have been prescribed the medications above, the Food and Drug Administration recommends you proceed taking them till an alternative treatment is in place, as a result of, “The risk of harm to the patient’s health could also be higher if the treatment is stopped immediately.”