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Medicine recalls

 
Australia: Recall - potential contamination: Dilart and Dilart HCT (valsartan)
 
Therapeutic Goods Administration (TGA) advises consumers and health professionals that Alphapharm (trading as Mylan Australia), in consultation with the TGA, is recalling all batches of Dilart (valsartan) and Dilart HCT (valsartan and hydrochlorothiazide) tablets in Australia due to the presence of trace amounts of an impurity.

The impurity, N-nitrosodiethylamine (NDEA), was found in some batches of valsartan made by an Indian manufacturing plant. This is a different impurity to one found in overseas valsartan products in Jul and Aug (N-nitrosodimethylamine (NDMA)) which were produced by manufacturers in China. While these impurities are classified as probable human carcinogens (substances that could cause cancer), they are also commonly found in a variety of foods, particularly smoked and cured meats, some drinking water, in air pollution and are associated with some industrial processes.

The risk posed by the impurity at the levels found in these tablets is very low. Patients should not stop their treatment without consulting a doctor or pharmacist, as suddenly stopping high blood pressure medication poses more risk than the impurity.

Please refer to the following website in TGA for details: http://www.tga.gov.au/alert/dilart-and-dilart-hct-valsartan-0

In Hong Kong, the above products are not registered pharmaceutical products.

Ends/Friday, Nov 23, 2018
Issued at HKT 16:00
 
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