Two local pharmaceutical firms have issued recalls for blood pressure medication after their drugs were found to contain potential carcinogens, the Food and Drug Administration (FDA) said, following similar recalls worldwide.
Taipei-based Synmosa Biopharma Corp (健喬信元醫藥生技) on Friday informed the agency that during a self-screening it had discovered that the active ingredient valsartan in its Vaks 80mg and Vaks 160mg tablets contained N-nitrosodimethylamine (NDMA), a substance suspected to increase the likelihood of cancer, the FDA said in a statement
The valsartan came from Tianyu Pharmaceutical Co (天宇), in China’s Zhejiang Province, and had the batch number 10230-160509, the agency said.
Photo provided by the Food and Drug Administration
The recall, which is to continue until June, affects about 660,000 million tablets produced by Synmosa in three batches, with the numbers B26541, B24691 and B22371, the agency said.
In addition, the FDA said it has found that Tianyu Pharmaceutical’s Valsartan was also used by Synpac-Kingdom Pharmaceutical Co (景德製藥), another Taiwanese pharmaceutical firm, to produce blood pressure medication.
The agency on Friday asked Synpac-Kingdom to recall its Disartan 80mg containing the ingredient, which would affect 577,000 tablets from two batches with the code numbers AGR098 and AGW118, it said.
The two firms aim to complete the recall by March 15, the FDA said.
The incident is the latest among several cases worldwide in which potentially tainted blood pressure medication has been recalled.
The US Food and Drug Administration in July and August last year announced recalls of blood pressure drugs containing valsartan that were contaminated with NDMA or a similar impurity, N-nitrosodiethylamine.
All of the recalled products had ingredients made in India or China.
FDA division head Hung Kuo-teng (洪國登) in December said that when the agency first heard of the potential problems in July, it began checking blood pressure drugs on the local market and asked drug makers to screen their own products for impurities.
The EU in summer and fall last year also launched global recalls of drugs after discovering that the valsartan they contained, which came from India, was contaminated, Hung said.
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