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Blood pressure medication recalled after carcinogenic substance found

2018/11/20 23:14:51

Image taken from www.genovate-bio.com

Taipei, Nov. 20 (CNA) Taiwan's Food and Drug Administration (FDA) has ordered the recall of high blood pressure medication produced by Hsinchu County-based Genovate Biotechnology Co. after the drug was found to contain a carcinogenic substance.

The recall was not made public until Tuesday, after 22 batches of "Prevan Film-Coated Tables 80mg" and "Prevan Film-Coated Tables 160 mg" from Genovate Biotech's production line were found to have been made with a raw material imported from India tainted by the carcinogenic chemical substance N-Nitrosodiethylamine (NDEA).

The company began recalling the contaminated medication Saturday, the same day the FDA ordered all tainted tablets be taken off shelves at medical institutes and pharmacies around the country, the agency said in a statement released on Tuesday.

FDA division chief Hung Kuo-teng (洪國登) told CNA via telephone that a total of 2.28 million tables -- labeled with the expiration dates July 30, 2022 and Nov. 4, 2019, respectively -- will be removed by Dec. 19.

He pointed out that the problematic tablets were produced with a material called "valsartan" by Indian pharmaceutical factory Mylan Laboratories Ltd.

The European Union recently launched a global recall after discovering Mylan-produced valsartan to contain NDEA, which can cause cancer among humans, Hung said, noting that the FDA has determined Genovate Biotech is the only company in Taiwan to have imported the problematic material from India.

He said the recall will not cause a shortage in the supply of high blood pressure drugs because the tainted medication accounts for less than 2 percent of the market in Taiwan.

(By Chang Ming-hsuan and Elizabeth Hsu)
Enditem/AW