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 medication bottles were distributed nationwide, it said. The recall, which was initiated voluntarily by Teva Pharmaceuticals, started on Oct. 7.
It says that the “source of nitrosamines can be related to the drug’s manufacturing process or its chemical structure or even the conditions in which they are stored or packaged” and noted that “as foods and drugs are processed in the body, nitrosamines can also be formed.”
The FDA says that nitrosamines are often found in water and foods, including cured and grilled meats, dairy products, vegetables, and other items, noting that everyone is exposed to some level of nitrosamines.
But long-term exposure to high levels of the carcinogenic substances may increase the risk of cancer, the FDA says.
“Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time, but a person taking a drug that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer,” according to a section on its website.
The FDA notice said that the drug recall is ongoing.
