FDA Orders Recall of Over 580,000 Bottles of Blood Pressure Drug

The U.S. Food and Drug Administration (FDA) has announced a recall of more than 580,000 bottles of the blood pressure medication prazosin hydrochloride due to concerns that it may contain a cancer-causing chemical. The recall, which was initiated earlier this month, involves products manufactured by Teva Pharmaceuticals USA in New Jersey and distributed by Amerisource Health Services.

Prazosin is commonly prescribed to relax blood vessels, thereby helping to lower blood pressure. It is also utilized in treating nightmares and sleep disturbances associated with post-traumatic stress disorder (PTSD). The FDA has classified the affected lots of this medication as a Class II risk, indicating that the potential health risks necessitate action.

According to the FDA’s enforcement orders, the recall was prompted by the discovery of N-nitrosamine impurities in some batches. These impurities are recognized as potentially cancer-causing chemicals that may form during the manufacturing or storage of certain drugs.

The recall affects various strengths of prazosin capsules, and the FDA is actively monitoring the situation to ensure consumer safety. Patients currently using this medication are advised to consult their healthcare providers regarding alternative treatments.

In an effort to mitigate health risks, the FDA encourages consumers to return any affected products to the point of purchase. The agency is committed to maintaining the safety and integrity of medications available to the public.

This recall highlights the ongoing vigilance required in the pharmaceutical industry to ensure that medications do not pose undue risks to patients. As the FDA continues to investigate the implications of the presence of N-nitrosamines and other impurities in medications, updates will be provided to keep the public informed.