The Ministry of Health (Minsa) Pharmacy and Drugs Department has ordered the suspension and use of batches of 53 products containing Valsartan, Irbesartan, Candesartan and Olmesartan, all for high blood pressure.
A resolution in the Tuesday, May 14 Official Gazette, said the decision was adopted as a precautionary measure.
Minsa indicates that to date several manufacturing laboratories have not presented the evidence demonstrating that they are free of nitrogenous impurities or comply with the internationally requested limits in Resolution No. 127 of February 11, 2019.
It also ordered distribution agencies, importers and manufacturers, to immediately withdraw all batches of the products that are on the list.
The director of Pharmacy and Drugs of the Minsa, Lisbeth Tristán de Brea, explained that the resolution issued on May 2, 2019, is the result of a work developed since July 2018, product of international alerts issued by pharmaceutical agencies from the European community and the United States Food and Drug Administration (FDA) on products to control hypertension (high blood pressure) .
The alerts are based on the need for these products to be free of impurities, as well as the demonstration that their production processes comply with the standards of good manufacturing practices.
Tristán said indicated that the products listed in the resolution are those that were given the opportunity until April to demonstrate with evidence that in their production process products were free of impurities.