Over 763,000 tablets were taken off the shelf, as the high blood pressure drug Amvalo (valsartan amlodipine besilate) was recalled due to contamination.
The tablets were manufactured in an undisclosed factory based in India between April and July 2018, and are subject to recall after the company’s review, which came after Japanese Health Ministry asked pharmaceutical firms to check whether any of their drugs using valsartan contained any carcinogenic impurities.
In a statement from Pfizer Japan, there have been no reports of any patients experiencing complications after taking the drug.
“We sincerely apologize for causing troubles and worries to all including those who engage in medical care. We will fully pay careful attention to our manufacturing and quality control to prevent a recurrence,” Akihisa Harada, president of Pfizer Japan, said in the statement.
The company’s president went on to say that the Pfizer subsidiary will pay careful attention to its manufacturing and quality control to prevent a recurrence.
While the company did not disclose the impurity, multiple sartan (valsartan, Iosartan, and irbesartan) recalls have been tied to the contamination of two possible carcinogens: N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA).
The US Food and Drug Administration recently made a statement regarding the identification of NDMA and NDEA in certain medicines, like that of Amvalo, and noted that the impurities may be formed from the reuse of solvents during the manufacturing process.
