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NEW YORK (WPIX) – A nationwide recall has been issued for a medication used to reduce the risk of hospitalization in patients with heart failure.
Nearly 1 million bottles of Corlanor, known generically as ivabradine, are being recalled because they may contain a foreign substance, according to a Food and Drug Administration (FDA) recall alert.
Corlanor is prescribed for adults with chronic heart failure to lower the risk of hospitalization due to worsening conditions. It is also used to treat children aged 6 months and older with stable heart failure symptoms caused by an enlarged heart, according to the Mayo Clinic.
The recall, which affects at least 934,577 bottles containing 5 mg tablets of Corlanor manufactured in Italy, is being voluntarily initiated by Amgen, Inc., the manufacturer of the medication.
Recall information
The recalled medication includes 5 mg Corlanor (ivabradine) tablets provided in both 14-tablet and 60-tablet bottles by prescription only. An undisclosed number of 7.5 mg tablets sold in 60-tablet bottles was also included in the recall, the FDA indicated.
Lot codes and expiration dates for each type of bottle can be found in the agency’s enforcement report.
A spokesperson for Amgen, Inc. said the company discontinued the medication and that only a limited amount of product is expected to remain in retail distribution.
The recall, which was initiated on June 4, has since been categorized as a Class II recall, meaning that use or exposure to the medication may cause temporary or reversible adverse health effects, according to the FDA.
More information is included in the FDA’s updated enforcement report.
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