The National Institute of Hygiene orders the removal of Valsartan from the market

The National Institute of Hygiene "Rafael Rangel" (INHRR), entity attached to the Ministry of Health, issued a Special Pharmaceutical Alert No. 013/2018 in which it states that it ordered the recall of all products containing the active ingredient Valsartan, supplied by the pharmaceutical company Zhejiang Huahai Pharmaceuticals of China.

The reason is that the presence of impurity N-nitrosodimethylamine (NDMA) has been detected, classified as "probably carcinogenic" according to the International Agency for Research on Cancer (IARC).
Valsartan is mainly used for the treatment of arterial and cardiovascular hypertension.

"The National Institute of Hygiene" Rafael Rangel "and representatives of companies: Laboratorios Klinos, CA, Vivax Pharmaceuticals Laboratories, CA, Laboratorios Leti SAV, Laboratorios Vargas, SA, Generic Quality, GC, CA, have determined how preventative measure immediately immobilize all units of the product that they own in their inventory and withdraw from the market all products distributed, "reads the document published on the website of the Institute.

In the case, he mentions that "the Spanish Agency for Medicines and Health Products (AEMPS) and the European Medicines Agency (EMA) issued a statement on July 5, 2018 a statement regarding the presence of NDMA impurity active substance Valsartan.
Ensure that the "National Institute of Hygiene" Rafael Rangel "continues with the verification of the raw material supplier of other products that contain Valsartan that are marketed in the country and will report in a timely manner to the community."

"The National Institute of Hygiene" Rafael Rangel ", informs the Community that the product continues under strict health surveillance and is urged, to notify any event or problem with the use of the drug ", the letter ends.