Siu Guan Chemical Industries – operating out of Chiayi, Taiwan – has instigated a recall of 3.2m tablets of Cosar F.C. 50mg, which are used to control blood pressure.
The company initiated the recall after its own investigation discovered impurities within the medicine.
The losartan used as an active ingredient in the medicine was found to contain N-Nitrosodiethylamine (NDEA), classified as a probable carcinogen.
According to a statement (link in Mandarin) released by the Taiwanese Food and Drug Administration, the company will recall the 11 batches over the course of January.
The agency also stated that it has strengthened its random testing procedure and has introduced requirements for the industry to conduct its own ‘self-inspections’.
Sin Guan was prompted to begin its tests after the discovery of contaminated valsartan products by the European Medicines Agency in July 2018.
After the initial recall of valsartan produced by Chinese manufacturer, Zhejiang Huahai, the investigation spread further to impact a number of companies. This led to the examinations of medicines produced using other ‘sartan’ medicines, such as losartan.
