Nearly 590,000 bottles of blood pressure medication have been recalled due to concerns they may contain harmful chemicals at levels considered unsafe.
This recall involves Prazosin Hydrochloride, initiated by Teva Pharmaceuticals USA on October 7 and Amerisource Health Services on October 26. A report from the U.S. Food and Drug Administration (FDA) revealed that these capsules might have nitrosamine impurities that exceed acceptable limits set by the Carcinogenic Potency Classification Approach.
The FDA points out that N-nitrosamine impurities can form during the manufacturing or storage of medications and are linked to cancer risk.
As of October 24, the FDA classified this recall as class II, indicating that using the affected products could lead to temporary or reversible adverse health effects, but the risk of serious complications is relatively low.
The recall is specific to 1 mg, 2 mg, and 5 mg prazosin hydrochloride capsules from Teva Pharmaceuticals USA and Amerisource Health Services, with certain lot numbers and expiration dates. Most of the recalled bottles, over 580,000, were distributed by Teva, while the remainder came from Amerisource.
Additional details regarding the recalled drugs, including lot codes and expiration dates, can be found in the FDA enforcement report.
Prazosin is typically prescribed to lower blood pressure by relaxing blood vessels. It can also be used for treating nightmares and other sleep disorders linked to post-traumatic stress disorder.
Patients who have taken the recalled medications should reach out to their healthcare provider or pharmacy for guidance. The FDA has cautioned that, in some cases, discontinuing a medication might lead to worse health effects than continuing with a recalled product.
