CUBA: WITHDRAWAL FROM THE MARKET OF SOME LOTS OF MEDICINES CONTAINING VALSARTAN.
On July 5, 2018, the Spanish Agency for Medicines and Health Products (hereinafter, AEMPS) has issued the Information Note 8/2018 in which it announces the detection of N-Nitrosodimethylamine (NDMA) φ in the active ingredient Valsartan manufactured by Zhejing Huahai Pharmaceutical Co. (Ltd (BS 1) Channan Site, RC-317016 (China) .This impurity has been generated as a consequence of a change in the manufacturing process of valsartan authorized by EDQM (acronym in English). European Directorate for the Quality of Medicines & HealthCare, European Directorate for the Quality of Medicines) of the Council of Europe This alert affects multiple countries at European and global level In the case of Spain, it affects several presentations of medicines that include valsartan produced by that manufacturer and that has been distributed in many countries.In Spain, after receiving the corresponding investigation has proceeded to order the withdrawal of medicines affected two.
More information by the link http://www.cecmed.cu/sites/default/files/adjuntos/vigilancia/notas/retirada_del_mercado_de_algunos_lotes_de_medicamentos_que_contienen_valsartan.pdf