Teva Pharmaceuticals has voluntarily recalled its amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide combination tablets, the U.S. Food and Drug Administration announced Tuesday.
According to a recall notice, the drugs contain too much N-nitroso-diethylamine, a chemical manufactured in Mylan, India. The ingredient, typically found in certain foods, drinking water and air pollution, has been classified as a human carcinogen by the International Agency for Research on Cancer.
Teva officials noted the company has not received any reports of illness, but it has asked its retailers to stop distributing the products and return them immediately.
Patients on the medications are advised to continue taking the tablets and to contact their doctor for advice for alternate treatments. An official with the company said, “the risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any comparable alternative treatment.”
The agency recently recalled three other blood pressure medications due to cancer concerns, and another was recalled for mislabeling.
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