Teva Pharmaceuticals has voluntarily recalled more than 580,000 bottles of prazosin hydrochloride, a high blood pressure drug, because of a carcinogenic ingredient.
In safety and quality testing of the medication, the drugmaker detected N-nitroso Prazosin impurity C, which can increase cancer risk if exposure exceeds acceptable levels set by the FDA.
The recall is classified as Class II, which the FDA defines as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Other drug manufacturers have previously detected higher-than-acceptable levels of nitrosamines, including Pfizer, Merck, Sandoz and Rising Pharmaceuticals.
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