The Food and Drug Administration (FDA) yesterday said that anti-hypertensive drugs produced in China that had been recalled and reported to contain a probable carcinogen were not imported to Taiwan.
The Hong Kong Department of Health on Friday recalled five prescription drugs made in China that are used to treat heart disease, because they were found to contain the chemical N-nitrosodimethylamine (NDMA), which can potentially cause cancer.
The department had detected NDMA — which is classified as a probable human carcinogen based on laboratory test results — in valsartan produced by a manufacturer in China.
The valsartan was used as an active ingredient in the recalled drugs: Valtensin 160mg tablets, Valtensin 80mg tablets, Valtensin HCT 160/12.5mg tablets and Valtensin HCT 80/12.5mg tablets registered to pharmaceutical company Actavis Generics, as well as Valsartan Stada 80mg tablets registered to Hong Kong Medical Supplies.
Following an alert by the UK’s Medicines and Healthcare Products Regulatory Agency, the British government on Thursday issued a news release, saying that pharmacies in the UK should “recall all batches of valsartan containing medicines made by Dexcel Pharma and Accord Healthcare (previously known as Actavis Group) as a precaution.”
The recall was under way across Europe, it said.
The five drugs being recalled were not imported to Taiwan, FDA official Chi Jo-feng (祁若鳳) said yesterday, but added that the manufacturer in question was Zhejiang Huahai Pharmaceutical Co Ltd (浙江華海製藥公司), which some Taiwanese pharmaceutical companies purchase raw materials from.
The administration is checking whether drugs produced in Taiwan contain the same problematic valsartan, she said.
The investigation results are to be announced next week at the earliest, and drugs are to be recalled if they are found to contain the probable carcinogen, Chi said.
Adittional reporting by CNA
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