Blood pressure drug recalled after carcinogenic substance found

Taipei, A biotech company has recalled its high blood pressure drug after finding that several batches of the medication contained a potentially cancer-causing substance, Taiwan's Food and Drug Administration (FDA) said Saturday.

Chiayi-headquartered Siu Guan Chemical Industrial Co. began on Thursday to recall its 50 mg Cosar F.C. Tablets after they were found to contain N-Nitrosodiethylamine (NDEA), a substance suspected of causing cancer, but the move was first made public Saturday.

The recall, which will continue until Jan. 27, 2019, involves 3 million tablets produced over 11 batches, the FDA said.

The incident is the latest of several cases of potentially tainted high blood pressure medication available in Taiwan and around the world.

The U.S. Food and Drug Administration announced recalls in July and August of blood pressure drugs containing the active ingredient valsartan that was contaminated with NDEA or a similar impurity, N-nitrosodimethylamine (NDMA).

All of the recalled products had ingredients made in India or China.

FDA division chief Hung Kuo-teng told CNA that when his agency first heard of the potential problems in July, Taiwan's FDA began checking blood pressure drugs on the market here and also asked drug brands to screen their own products for impurities.

Siu Guan Chemical was one of the companies that examined their own products, and it informed the FDA that it had detected the presence of NDEA and would initiate a recall, Hung said.

The code numbers of the 11 batches of 50 mg Cosar F.C. Tablets being recalled are 601233, 601243, 606193, 607023, 607033, 609173, 610013, 610023 and 602043.

Prior to the Siu Guan Chemical case, the most recent recall of a high blood pressure medication in Taiwan came in November for a product made by Hsinchu County-based Genovate Biotechnology Co. that the agency also found to contain impurities.

According to Hung, the European Union also recently launched a global recall after discovering that valsartan made in India was contaminated.

Source: Overseas Community Affairs Council