More than 700,000 bottles of the blood pressure drug carvedilol have been recalled across the United States due to the presence of a carcinogenic substance, with the Food and Drug Administration (FDA) upgrading the recall to Class II.
The FDA said a total of 732,960 bottles of carvedilol tablets in various dosages are under recall, according to an updated list of enforcement reports issued on June 4. The recall was initiated in February, but the FDA upgraded its classification last week.
The carvedilol tablets, manufactured by New Jersey-based Glenmark Pharmaceuticals Inc., contain an “N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit,” the FDA said….