《TAIPEI TIMES》 High blood pressure drug recalled over contaminant
A box of Cosar F.C. high blood pressure tablets made by Chiayi-based Siu Guan Chemical Industrial Co is pictured in an undated photograph. Photo copied by Wu Liang-yi, Taipei Times
/ Staff writer, with CNA
A biotechnology company has recalled its drug for high blood pressure after finding that several batches contained a potential carcinogen, the Food and Drug Administration said yesterday.
Chiayi-headquartered Siu Guan Chemical Industrial Co (壽元化學工業) on Thursday began to recall 50 milligram tablets of Cosar F.C. after they were found to contain N-nitrosodiethylamine (NDEA), a suspected carcinogen, but it was only made public yesterday.
The recall, which is to continue until Jan. 27, involves 3 million tablets produced in 11 batches, the agency said.
The incident is the latest in a string of cases of potentially tainted blood pressure medication available in Taiwan and worldwide.
The US Food and Drug Administration in July and August announced recalls of blood pressure medication containing the active ingredient valsartan that was contaminated with NDME or a similar impurity, N-nitrosodimethylamine.
All of the recalled products had ingredients made in India or China.
When the Taiwanese agency heard of potential problems in July, it began checking blood pressure drugs on the domestic market and asked drugmakers to screen their products for impurities, division head Hung Kuo-teng (洪國登) said.
Siu Guan Chemical was one of the companies that examined their own products, Hung said, adding that it informed the agency that it had detected the presence of NDEA and would initiate a recall.
The code numbers of the 11 batches of Cosar F.C. 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 was last month for a product made by Hsinchu County-based Genovate Biotechnology Co (健亞生物科技) that the agency also found to contain impurities.
The EU also launched a global recall after discovering that valsartan made in India was contaminated, Hung said.
新聞來源:TAIPEI TIMES