Investigation of Valsartan medicinal products for evidence of active substance contamination – an update


Additional recall of batches from a second Chinese Valsartan manufacturer in Germany – no products in Switzerland affected to date

It became known around Europe a week ago that the potentially carcinogenic N nitrosodimethylamine (NDMA) had not only been found in Valsartan from the Chinese producer Zhejiang Huahai Pharmaceutical but was also potentially present in this active substance from the manufacturer Zhejiang Tianyu. Further batch recalls are thus taking place in Germany.

As far as is known at present, Switzerland is not affected by this new development.

The responsible regulatory authorities are currently undertaking investigations around the world to establish whether Valsartan active substances from various manufacturers might contain traces of NDMA, and if so in what concentrations. Should these investigations indicate that not all potentially contaminated products or batches have been recalled from the market in Switzerland, Swissmedic will take immediate action and inform the public accordingly.

As before, there is no acute threat to patient health. Patients should not stop taking blood pressure-lowering medicines containing Valsartan without first consulting their doctor. Discontinuing these medicines would pose a far greater risk to health than the possible risk presented by the reported impurities. Affected persons should contact their doctor or pharmacist if they have any questions.

Patients who wish to find out if their product has been recalled as a precautionary measure can consult the recall list for Valsartan-containing medicinal products.