The drugs, including losartan, belong to a class of widely used medicines for treating high blood pressure called angiotensin II receptor blockers, or ARBs.
In a statement, FDA Commissioner Scott Gottlieb explained that the agency has been carrying out a series of investigations for several months after various companies began announcing their voluntary recalls. Its announcement is an expansion to a recall that the company first initiated in December 2018 on 80 lots.
Camber Pharmaceuticals Inc. voluntarily recalled 87 lots of losartan tablets in the United States on Thursday. The active drug ingredient was made at Hetero Labs Restricted in India, one in all two overseas drug factories linked to repeated blood treatment recollects since final July.
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The FDA says no one has reported any adverse effects from the drug and patients should speak with their doctor to discuss the recall before they stop taking the drug. The affected products come in 25, 50 and 100 milligram doses. The recalled tablets, made by Hetero Labs Ltd.
A full list of lot numbers and expiration dates can be found here.
The U.S. Food and Drug Administration has found a third type of cancer-causing impurity leading to the recall of blood pressure medications.
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Global authorities have been clamping down on sales of some blood pressure medicines as they are suspected to be tainted with two probable carcinogens - N-nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA). "Because of the potential for discovering other nitrosamine impurities, we are conducting an extensive organic chemistry analysis to develop novel testing methods to detect additional nitrosamine impurities, including NMBA", he said.
The FDA will continue to update the list of products included in the recall as more information becomes available from ongoing testing. Friday, Torrent recalled 60 lots of Losartan potassium tablets and 54 lots of Losartan potassium/hydrochlorothiazide tablets because of NMBA's presence.
"The FDA is committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes in the future", he added.
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