Two more Chinese drugmakers have said that a blood-pressure medication they exported to Taiwan contained a potentially cancer-causing impurity, a month after the same problem at another Chinese manufacturer prompted a global recall.
Tianyu Pharm and Rundu Pharma said batches of valsartan, an active ingredient widely used in medications for high blood pressure and congestive heart failure, contained N-nitrosodimethylamine (NDMA), which is believed to potentially cause cancer through long-term use.
Tianyu Pharm made its announcement yesterday in a statement to the Shenzhen Stock Exchange, where both companies are listed, while Rundu said the same in an exchange statement on Friday.
Tianyu Pharm said the problem was caught before its valsartan was distributed to end users in Taiwan, while Rundu Pharma said its products made it onto Taiwan’s market, but would be recalled.
The Food and Drug Administration on Thursday ordered a recall of 24.21 million tablets of heart medicine valsartan supplied by Zhuhai Rundu Pharmaceutical Co were found to be tainted.
The recall was instigated after it was discovered that Zhuhai’s valsartan contained NDMA.
The four types of medicines affected are the Valsart FC Tab 160mg, Valsart FC Tab 80 mg, Asartan FC Tab 5/80mg and the Valsart-H FC Tablets 80/12.5mg, which is produced by Standard Chem & Pharm Co in Taiwan.
More than 10 million tablets from six types of valsartan medicine supplied by Zhejiang Huahai Pharmaceuticals were recalled last month after they were found to be tainted by NDMA.
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