More than 580,000 bottles of blood pressure medication are being recalled across the United States due to possible carcinogenic substances, according to a notice from the Food and Drug Administration (FDA).
The recall involves three separate lots of prazosin hydrochloride, a type of alpha-blocking medication, that were distributed by New Jersey-based Teva Pharmaceuticals, because a test result for N-nitroso Prazosin impurity C found that the substance’s levels are above the “acceptable intake limit” under a type of test for carcinogens.
The recall encompasses three dosages for prazosin hydrochloride capsules, according to the notice. They include 181,659 bottles of 1-milligram doses of the drug, 291,512 bottles of 2-milligram doses, and 107,673 bottles of 5-milligram doses.
It means that the medication contained higher than acceptable levels of nitrosamines, which are carcinogenic compounds that can increase the risk of cancer when taken at high doses over long periods.
The FDA classified the recall on Oct. 24 as Class II, which the agency says is a scenario where a product, drug, or food “may cause temporary or medically reversible adverse health consequences” or it includes “an outcome where the probability of serious adverse health consequences is remote.”
The medication bottles were distributed nationwide, it said. The recall, which was initiated voluntarily by Teva Pharmaceuticals, started on Oct. 7.
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