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July 18, 2018. – The laboratory VIVAX has informed by a declaration, the voluntary withdrawal of products containing the active ingredient valsartan, such as Presincal, Valsartan and Varteral, due to the alert issued by the company. Spanish Agency for Medicines and Health Products (AEMPS) and the European Medicines Agency (EMA).
The health notification indicates the discovery of an alleged impurity in the active ingredient, the raw material used in the drugs for hypertension, which is produced by a laboratory located in China, a company listed as the One of the largest manufacturers in the world.
The VIVAX Laboratory has voluntarily decided to take preventive and responsible measures according to what happened, while the investigations are concluded by the international entities, for this reason it will immobilize all the units of products in his inventory.
The press release also informs that, through the intermediary of a specialized company, it will analyze the representative samples of the batches kept, in order to assess the presence of impurity and to evaluate a new supplier ensuring the presence of the active ingredient. without impurity, to revive the marketing of the drug containing valsartan.
Laboratorio VIVAX details that at the time of release, they are activating the withdrawal of antihypertensive drugs in identified establishments, and point out that not all products manufactured by the company have been affected by this "punctual inconvenience". [19659002]
Finally, the laboratory formally requests the suspension of the marketing of drugs, until they issue new information.
It should be recalled that the pharmaceutical notification published by the AEMPS, announces the discovery of N-nitrosodimethylamine, in the active ingredient valsartan, which is manufactured by the pharmaceutical company Zhejiang Huahai. According to the International Agency for Research on Cancer of the World Health Organization (WHO), this chemical compound is probably a carcinogen to humans
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