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Published: Wednesday, August 22, 2018 @ 8:24 AM
Updated: Wednesday, August 22, 2018 @ 8:24 AM
— The U.S. Food and Drug Administration has again expanded the list of medications under recall because of a chemical impurity that could put patients at risk of getting cancer.
Officials with the FDA announced Friday that Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of its valsartan/amlodipine/hydrochlorothiazide tablets after trace amounts of N-nitrosodimethylamine (NDMA) were found in one of the drug’s active ingredients. On Tuesday, the list of medications under recall grew to include all lots of Torrent Pharmaceuticals’ valsartan/amlodipine/hydrochlorothiazide, valsartan/amlodipine and valsartan tablets.
Authorities last month recalled some drugs containing valsartan, a medication used to treat heart failure and blood pressure that’s often a component of generic medicines, because they contained NDMA.
The chemical has been linked to an increased risk of cancer in animal studies, according to the FDA. However, the studies used higher levels of NDMA than those found in the recalled valsartan, officials said.
As of Tuesday, Torrent Pharmaceuticals had received no reports of illnesses related to the recall.
Valsartan was previously recalled in 22 other countries, according to CNN. The current recall is centered around valsartan manufactured in Linhai, China, FDA officials said.
Authorities believe the impurities were caused by a change in the way the drug was manufactured. Officials said in an update last week that the FDA is working with drug manufacturers “to ensure future valsartan active pharmaceutical ingredients are not at risk of NDMA formation.”