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Teva Pharmaceuticals USA and drug distributor Amerisource Health Services has recalled more than half a million bottles of a blood pressure medication over concerns it was made with a potentially cancer-causing chemical, the U.S. Food and Drug Administration says. The recall of prazosin hydrochloride capsules was initiated in mid-October due to a failed impurities/degradation specification. The capsules were flagged for levels of N-nitroso Prazosin impurity C that exceed the acceptable intake limit. Here's what to know. Why Is Blood Pressure Medicatino Being Recalled? This voluntary, nationwide recall was initiated because the medication tested positive for N-nitroso Prazosin impurity C, part of a class of chemical compounds that may increase the risk of cancer, according to the FDA. Nitrosamines are common in water and foods, and everyone is exposed to them to some degree, according to the FDA. "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," the agency said. However, the concentration in these bottles of prazosin hydrochloride exceeds acceptable limits. "Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time," per the FDA. The FDA has classified this recall as Class II, which is applied to “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.” Which Products Are Being Recalled? The recalled bottles of prazosin hydrochloride include: Prazosin Hydrochloride, Capsules, USP, 1 mg: 181,659 bottles Prazosin Hydrochloride, Capsules, USP, 2 mg: 291,512 bottles Prazosin Hydrochloride, Capsules, USP, 5 mg: 107,673 A full list of the recalled blood pressure medication is also available on the California State Board of Pharmacy website. What Is Prazosin Hydrochloride? Prazosin hydrochloride is a hypertension, also known as high blood pressure, medication. It’s part of a class of drugs called antihypertensives, which work to relax the blood vessels. “High blood pressure adds to the workload of the heart and arteries,” says the Mayo Clinic. “If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.”
