November 4, 2018
This time Teva Pharmaceuticals (TEVA) has issued a voluntary recall of two blood pressure medications which includes all lots of Amlodipine/Valsartan combination tablets and Amlodipine/Valsartan/Hydrochlorothiazide combination tablets. The recalled tablets are used to treat high blood pressure. This is due to the impurity named N-nitrosodiethylamine (NDEA) found at the above limit in the active pharmaceutical ingredient of Valsartan, manufactured by Mylan India. Recently, we have seen another recall for a blood pressure medication Losartan by Sandoz Inc. That recall was also due to the same NDEA contamination.
NDEA is an organic chemical, classified as probable human carcinogen, could cause cancer. This substance occurs naturally in certain foods, drinking water, air pollution, and industrial processes (e.g. pesticide manufacture, fish processing). For an example, NDEA was found previously in a drinking water well near a rocket engine testing facility, California.
Still today, no adverse effect is reported from the user. It is recommended to consult a pharmacist or physician before discontinuing use of this drug for medication of hypertension. Discontinuation may be very risky to the patients until they have an alternative medication.