The health watchdog found the impurity in the active substance valsartan manufactured by Zhejiang Huahai Pharmaceuticals in China. The appearance of the impurity - N-nitrosodimethylamine - came after a change in the process for making valsartan.
Accordingly, the administration ordered departments of health and pharmaceutical businesses to suspend the circulation of all drugs made from Valsartan of Zhejiang Huahai Pharmaceutical.
Importers have to coordinate with distributors to recall all such medicines in retailers and wholesalers.
Moreover, manufacturers must stop using the ingredient to make finished drugs. Scientists must re-assess the providers, check and research how to use Valsartan safely. They are requested to complete paper formalities as per the regulations.
Retailers and importers must report the quantity of drug sold to markets, recall medicines and receipt of drug removed from retailers and wholesalers to the Administration within one month.
Health departments in cities and provinces must check the recall and publicize the information in its website as well as issue fines on retailers and wholesalers which don’t follow the request.
