More than half a million bottles of the widely used blood pressure medication Prazosin Hydroclide are being recalled amid concerns that it contains unsafe levels of a cancer-causing chemical, and the drug company is telling patients taking the drug to contact their doctor or pharmacy if they have the product.
New Jersey-based Pharmaceuticals USA Inc. began recalling 580,844 bottles of Prazosin Hydroclide capsules that had been distributed nationwide on Oct. 7. According to Teva, the drug is available in doses of 1 mg, 2 mg, and 5 mg.
A total of 55 lots of pills were recovered. A full list of affected lot codes can be found here..
The capsules were recalled because tests “found them to exceed acceptable intake limits,” according to an enforcement report from the Food and Drug Administration. N-nitrosoprazosin impurity CThis is a compound linked to cancer.
According to the FDA: N-nitrosamine impurities A class of potentially carcinogenic chemicals that can form during the manufacture or storage of drugs.
On October 24, the recall was classified as “Class II.” This means the product “may cause temporary or medically reversible adverse health effects,” or if serious adverse health effects are unlikely, the FDA said.
According to Teva USA’s health risk assessment, the overall harm to the patient population is considered moderate. California Board of Pharmacy said in the note.
What should I do if I take medication?
In a statement to NBC Chicago, Teva said people taking the affected drugs should contact their pharmacies to determine what to do with any remaining quantities. It also said it had sent recall letters to customers with instructions to return the recalled products.
Teva said it had not received any “relevant complaints” related to the product.
“Prazosin is used to treat high blood pressure and lower blood pressure, and there are many alternative treatments available to patients,” the statement said. “At Teva, patient safety and product quality are our top priorities at every stage of the pharmaceutical life cycle.”
“Consumers with questions or concerns should also contact their health care provider who prescribed the medication,” Teva said.
This drug, more commonly called Prazosin, is a type of alpha-blocker that helps relax blood vessels and lower blood pressure. Doctors may sometimes prescribe it for nightmares and other sleep disorders caused by post-traumatic stress disorder.
Last month, Lipitor, a widely used cholesterol treatment, was also recently recalled for failing to meet dissolution standards. This suggests that the drug does not dissolve properly at a standard rate, which may reduce its efficacy.
