Heart failure drug recalled due to risk of contamination
Amgen is recalling 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.
The recall includes specifics lots of 5-mg and 7.5-mg Corlanor tablets manufactured in Italy and then distributed by Amgen throughout the United States. The drugs are packaged in 14- and 60-tablet bottles. Expiration dates range from July 2026 to December 2028.
The U.S. Food and Drug Administration (FDA) has categorized this as a Class II recall, which means taking the drugs in question could cause “temporary or medically reversible adverse health consequences.”
Amgen first received FDA approval for ivabradine in April 2015. The agency’s decision was largely based on data from the SHIFT trial, which included more than 6,500 patients randomized patients treated with ivabradine or a placebo. In 2021, researchers found that ivabradine could be used to treat symptoms associated with postural orthostatic tachycardia syndrome in COVID-19 patients.
Click here for more details from the FDA.
Other recent pharmaceutical recalls
Back in May, 675 bottles of enalapril maleate tablets manufactured by Unique Pharmaceutical Laboratories and distributed by Rising Pharma Holdings were recalled due to a failed Organic Impurities Test.
In the middle of June, 11,460 bottles of chlorthalidone tablets manufactured by Inventia Healthcare Limited and distributed by Rising Pharma Holdings were recalled 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.