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(RNN) – The US Food and Drug Administration has announced the recall of several drugs containing the active ingredient, valsartan, which is used to treat hypertension and insufficiency heart.
According to the FDA, an impurity N-nitrosodimethylamine, or NDMA, was found in the recalled drugs.
The FDA has called NDMA a "probable human carcinogen."
"The presence of NDMA was unexpected and it is thought to be related to changes in the way the active substance was made," the FDA said in its announcement on Friday.
The recall does not include all products containing valsartan; Valsartan medications manufactured by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd. are recalled, as are valsartan / hydrochlorothiazide (HCTZ) from Solco Healthcare and Teva Pharmaceuticals Industries Ltd.
"We carefully evaluated drugs containing valsartan sold. In the United States, we found that Valsartan sold by these companies did not meet our safety standards, which is why we asked these companies to take immediate action to protect patients, "said Janet Woodcock , MD, Director The FDA has stated that users of the recalled medications should continue to take them until they find a replacement, and that they should consult their health care professionals to discuss plans for their treatment in progress.
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