Blood pressure drug recalled due to failed test
More than 28,000 bottles of ramipril capsules have been recalled after a failed test. The U.S. Food and Drug Administration (FDA) has categorized this as a Class II recall, which means it “may cause temporary health consequences, but the probability of a serious health issue is remote.”
The drugs in question were manufactured by West-Ward Columbus in Ohio, a part of Hikma Pharmaceuticals USA, and then distributed by Exelan Pharmaceuticals in Florida. The two lots included in this Class II recall both expire in July 2027.
These capsules contain a generic version of ramipril, an ACE inhibitor often prescribed to help patients control their blood pressure. It is also sometimes given to high-risk patients, including those who are recovering from a heart attack, to help protect them from adverse cardiac events.
What caused this recall?
These capsules were recalled due to failed impurities/degradation specifications. The drug produced an out-of-specification test result associated with dicyclohexylurea.
A recent history of drug recalls impacting cardiology
In August, Novartis recalled a single lot of valsartan, a blood pressure drug the company sells under the brand name Diovan, due to failed dissolution specifications.
Earlier that same month, Ascend Laboratories recalled multiple lots of dabigatran etexilate, a blood thinner taken to reduce the risk of stroke or blood clots in patients with nonvalvular atrial fibrillation. The recall was put in place due to a failed impurity/degradation test.
In late June, Amgen had to recall nearly 935,000 bottles of ivabradine, a heart failure drug the company sells under the brand name Corlanor, due to the presence of a foreign substance.
In the middle of June, meanwhile, JB Chemicals and Pharmaceuticals recalled more than 11,000 bottles of a water pill. Like the most recent Diovan recall, this was due to failed dissolution specifications.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.