Teva Canada expands recall of valsartan drugs to include additional lots

Health Canada is advising Canadians that, as a precautionary measure, Teva Canada is expanding its voluntary recall to include eight additional lots of valsartan products in Canada because they may contain an impurity, N-nitrosodimethylamine. Valsartan is used to treat high blood pressure and heart failure.This latest action is further to an initial recall of certain valsartan products because of the presence of NDMA in the active ingredient. All of the recalled products use a valsartan ingredient manufactured by Zhejiang Huahai Pharmaceuticals in China. Health Canada is reviewing the long-term potential health impacts of the NDMA impurity on patients. The additional Teva Canada products are being recalled after sample testing of the active ingredient by Zhejiang Huahai Pharmaceuticals identified trace levels of NDMA. Testing is ongoing. In the meantime, Health Canada has asked Teva Canada to recall these additional products as a precautionary measure, and to conduct a full investigation to determine the root cause of this most recent issue.

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