FDA: impurity in an active ingredient, | Irbesartan blood pressure medication voluntary recalling

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A drug company has recalled more irbesartan blood pressure medication after discovering a potential human carcinogen.

Prinston Pharmaceutical, doing business as Solco Healthcare, has voluntarily recalled of eight more lots of Irbesartan blood pressure medication after detecting trace amounts of impurity in an active pharmaceutical ingredient, the Food and Drug Administration announced Friday.

The ingredient in question contains N-nitrosodiethylamine (NDEA), "a substance that occurs nationally in certain foods, drinking water, air pollution, and industrial processes" and has been classified by the International Agency for Research on Cancer as a probable human carcinogen.



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