Teva Pharmaceuticals USA, based in Parsippany, New Jersey, issued a voluntary recall on Oct. 7 for some of the prazosin hydrochloride capsules it distributed over a cancer-causing chemical connected to the prescription drug. FDA classified it as a Class II risk level on Friday, Oct. 24. The drug was approved by the FDA to treat high blood pressure, but sometimes physician prescribe an off-label use to help manage symptoms of PTSD, particularly nightmares and sleep problems. The medication relaxes blood vessels to improve blood flow and reduce blood pressure.
A Class II recall indicates 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. The medication may contain nitrosamine impurities also called “N-nitroso Prazosin impurity C.” Exposure to the product can lead to severe health risks, the FDA reported.
