The Food and Drug Administration posted notices on recalls of tens of thousands of bottles of two different types of blood pressure and heart medications, upgrading them to the second-highest classification.
In several recall notices posted between Aug. 12 and Aug. 14, the FDA confirmed the recalls of 88,032 bottles of carvedilol tablets, a drug primarily used to treat high blood pressure, or hypertension, and heart failure.
The reason for the recall is due to an elevated presence of the nitrosamine N-nitroso carvedilol I, which was deemed to be “above the current” acceptable intake level, the FDA said.
A nitrosamine is a type of organic compound considered carcinogenic, which can potentially cause cancer, officials say. The FDA website has a section about pharmaceutical medications that have nitrosamine impurities, issuing guidance in 2024 on how companies can comply with the agency’s regulations on the substances….