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Medication Used to Treat Heart Failure Recalled Nationwide
Amgen is recalling nearly 1 million bottles after the FDA said the heart failure drug may contain a foreign substance.
Amgen, Inc. initiated a nationwide Class II recall on June 4 for nearly 1 million bottles of Corlanor after unexpected foreign matter was discovered in a reserve sample, affecting at least 934,577 bottles of the medication.
Unexpected foreign matter found in a reserve sample triggered the recall; the Food and Drug Administration categorized it as Class II, indicating use or exposure may cause temporary or reversible adverse health effects.
Affected products include 5 mg Corlanor tablets in 14-tablet and 60-tablet bottles, plus an undisclosed number of 7.5 mg tablets; lot codes and expiration dates are available in the FDA enforcement report.
An Amgen spokesperson confirmed the company discontinued the medication, with only a limited amount of product expected to remain in retail distribution following the recall.
Corlanor treats adults with chronic heart failure and children aged 6 months and older with stable heart failure symptoms, according to the Mayo Clinic, lowering hospitalization risk.