TOKYO: The Japanese subsidiary of Pfizer is recalling a drug for high blood pressure which was found to contain a carcinogenic substance in its active ingredient valsartan, the drugmaker said on Friday.
More than 763,000 tablets of the drug Amvalo, manufactured from April to July in Mylan Laboratories Limited in India, are the subject of recall, Pfizer Japan Inc said in a statement, adding there were no reports of any damage to health.
Company officials said there have been no reports of any damage to anyone’s health, but they’re still proceeding with the recall out of caution.
The recall is due to the discovery of trace amounts of an unexpected impurity in a pharmaceutical ingredient known as N-nitrosodiethylamine (NDEA), which the FDA has classified as a “probable human carcinogen.”
“We will fully pay careful attention to our manufacturing and quality control to prevent a recurrence,” Pfizer Japan President Akihisa Harada said.
Mylan NV said in November it would recall certain batches of blood pressure medicine valsartan in the United States after they were found to contain a probable cancer-causing impurity.
Chinese pharmaceutical ingredient manufacturer Zhejiang Huahai Pharmaceuticals also said in July it would recall valsartan from consumers in the United States after finding traces of a probable carcinogen.
The additional 104 lots were being taken off shelves “out of an abundance” of caution, company officials said, because of reports that valsartan products may contain traces of a potential cancer-causing impurity.
Last year, the Japanese Health Ministry asked pharmaceutical firms to check whether any of their drugs using valsartan contained any carcinogenic impurities.