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Blood pressure drugs recalled after cancer-causing materials found

2019/02/16 14:15:14

Courtesy of Taiwan's FDA

Taipei, Feb. 16 (CNA) Two Taiwanese pharmaceutical firms have launched a recall of drugs for treating high blood pressure after they were found to contain a potentially cancer-causing substance, according to the Taiwan Food and Drug Administration (FDA).

In a statement, the FDA said Taipei-based Synmosa Biopharma Corp. informed the agency on Friday that after its self-screening, the active ingredient Valsartan in its Vaks 80mg and Vaks 160mg drugs was found to contain N-nitrosodimethylamine (NDMA), a substance suspected of causing cancer.

The NDMA came from Zhejiang-headquartered Tianyu Pharmaceutical Co. coded 10230-160509, the FDA said.

The recall, which will continue until June, involves about 660,000 million tablets produced by Synmosa in three batches with the code numbers of B26541, B24691 and B22371, the FDA said.

In addition, the FDA said it has found the Zhejiang company Tianyu's ingredient Valsartan was also used by Synpac-Kingdom Pharmaceutical Co., another Taiwanese pharmaceutical firm, to produce high blood pressure drugs.

As a result, the FDA asked Synpac-Kingdom on Friday to recall its Disartan 80mg containing the ingredient and the recall will involve a total of 577,000 tablets in two batches with the code numbers of AGR098 and AGW118, according to the agency.

The recall by the two Taiwanese pharmaceutical firms will be completed by March 15, 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 2018 of blood pressure drugs containing the active ingredient valsartan that was contaminated with NDMA or a similar impurity, N-Nitrosodiethylamine (NDEA).

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

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

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

(By Chang Ming-hsuan and Frances Huang)
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