Amgen, Inc. — Class II: Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks
Amgen, Inc. has initiated a Class II recall for Corlanor (ivabradine) 7.5mg tablets in 60-count bottles due to the presence of a foreign substance. The recall is currently classified as ongoing and involves products manufactured in Italy.
This recall impacts Amgen, Inc., specifically involving their Thousand Oaks, CA facility and the manufacturing site in Italy. It affects quality control, manufacturing, and supply chain personnel responsible for the Corlanor product line.
A Class II recall indicates that the product may cause temporary or medically reversible adverse health consequences, though the probability of serious adverse consequences is remote. The presence of a foreign substance suggests a potential breach in manufacturing controls or contamination during the production process. Regulatory teams may need to evaluate the impact on the overall supply of ivabradine and assess if this issue reflects a systemic problem with the specific manufacturing site.
QA teams should verify if affected lot numbers are present in their inventory and initiate quarantine procedures. Manufacturing and supply chain departments should investigate the origin of the foreign substance and assess potential risks associated with the Italian manufacturing site. Regulatory affairs should monitor the ongoing status of the recall for further updates or expansion.
Class II. Reason: Presence of Foreign Substance.. Product: Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60. Firm: Amgen, Inc. (Thousand Oaks CA United States). Status: Ongoing.
Open in openFDA / FDA.gov