Traces of N-nitrosodimethylamine, or NDMA, were found in medications that contain the ingredient valsartan.
The Ministry of Food and Drug Safety announced the research results soon after NDMA was detected in valsartan-containing products made in Korea and banned the manufacturing and sales of 59 valsartan-based hypertension tablets from 22 pharmaceutical companies. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them.
For more information on the recall, visit the FDA's website.
China's Zhejiang Huahai Pharmaceutical last month reported that after making its discovery it had suspended manufacturing and supply of valsartan, sealed its unshipped batches and informed customers and regulators, including the FDA. Novartis in a statement said its branded products and those made for the USA are unaffected but that it is recalling recalling Sandoz's valsartan and valsartan HCT distributed in 23 countries. "The agency reminds manufacturers to thoroughly evaluate their API manufacturing processes, and changes to those processes, to detect any unsafe impurities".
Other products that recorded more than 1 billion won of total sales previous year include JW Pharmaceutical's Valsaforce (3.71 billion won), Aju Pharmaceutical's Anafurge (1.57 billion won), Myungmoon Pharmaceutical's Exnin (1.12 billion won) and Daehwa Pharmaceutical's Varoforge (1.01 billion won). Still, the FDA says those can be stopped once another medication is approved by a doctor or pharmacist.
If you take this medicine, the American FDA has updated its recall and also published a list of Valsartan products not now recalled.