Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

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Defect Levels Handbook

Teva Pharmaceuticals has initiated a voluntary recall in the USA, to the individual level, of lots of Amlodipine / Valsartan mix pills and Amlodipine / Valsartan / Hydrochlorothiazide mix pills (see table below) because of an impurity detected preceding specification limitations within an active pharmaceutical ingredient (API) made by Mylan India.
The impurity located in Mylan’s valsartan API is popularly referred to as N-nitroso-diethylamine (NDEA), that was classified as a probable human carcinogen. This compound is usually found in tiny quantities in certain foods, including drinking water, air pollution, and certain industrial processes.



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