The FDA withdraws a number of drugs containing valsartan due to the detection of the substance N-nitrosodimethylamine (NDMA), which is a potential oncogene.
Oncogenicity of NDMA was previously confirmed in the laboratory conditions. The detection of this substance in the medicines was a surprise. It is assumed that appearance of the substance is associated with a violation of the technology of production of medicines. Valsartan is used in the treatment of hypertensive patients.
The FDA notes that not all the drugs with valsartan are included in the stop list. The list includes Valsartan manufactured by Major Pharmaceuticals, Solco Healthcare, Teva Pharmaceuticals Industries Ltd., and Valsartan / Hydrochlorothiazide manufactured by Solco Healthcare and Teva Pharmaceuticals Industries Ltd. The manufacturer of these medicines was Zhejiang Huahai Pharmaceutical Co. Ltd., where, as assumed, the violations were committed.