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Torrent Pharmaceuticals Limited has extended its voluntary booster of losartan potassium tablets after discovering traces of an "unexpected impurity".
The expanded recall includes three additional batches of losartan potassium tablets USP and two batches of losartan potassium / hydrochlorothiazide tablets.
The impurity is N-methylnitrosobutyric acid. Torrent only recalls a lot of losartan NMBAs above the acceptable daily intake levels published by the FDA.
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Losartan belongs to a class of drugs used to treat high blood pressure, angiotensin II receptor antagonists. Some generic versions of other ARAs, such as valsartan and irbesartan, have also been recalled.
Losartan is used to treat hypertension, hypertensive patients with left ventricular hypertrophy and treatment of nephropathy in patients with type 2 diabetes. 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 drug recall for blood pressure and the heart of major pharmaceutical companies, Solco Healthcare, Teva Pharmaceuticals Industries, Mylan Pharmaceuticals, Prinston Pharmaceuticals, Macleods Pharmaceuticals Limited, Camber Pharmaceuticals and Torrent.
To address the shortages caused by these recalls, the FDA approved in March a generic form of the drug for Diovan blood pressure, or valsartan.
If the above medications have been prescribed to you, the Food and Drug Administration recommends that you continue to take them until you set up an alternative treatment because "the risk of getting into the patient's health may be higher if the treatment is stopped immediately. "
A list of recalled items is available at the FDA.gov address. Consumers who have 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 to 5:00 pm Eastern Time and [email protected].
© 2019 Cox Media Group.
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