Amgen, Inc. — Class II: Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99),
Amgen, Inc. has initiated a Class II recall for Corlanor (ivabradine) 5 mg tablets due to the presence of a foreign substance. The recall covers 14-count and 60-count bottles manufactured in Italy and is currently classified as ongoing.
This recall affects Amgen, Inc., wholesalers, and pharmacies distributing Corlanor (ivabradine) 5 mg tablets. It also impacts professionals in Quality Assurance, Manufacturing, and Supply Chain roles responsible for product integrity and adverse event monitoring.
A Class II recall indicates that the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. The presence of a foreign substance suggests a potential breakdown in current Good Manufacturing Practice (cGMP) controls during production or packaging. For regulatory teams, this highlights the necessity of robust oversight for international manufacturing sites and thorough investigation into the source of the contaminant.
Verify existing inventory against the specific NDC and bottle counts listed. QA teams should review incoming material inspection protocols and supplier quality agreements, particularly for products manufactured internationally, to better detect or prevent the introduction of foreign substances during the tableting or packaging process.
Class II. Reason: Presence of Foreign Substance.. Product: Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy.. Firm: Amgen, Inc. (Thousand Oaks CA United States). Status: Ongoing.
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