Amgen, Inc. — Class II: Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One
Amgen, Inc. has initiated an ongoing Class II recall for Sensipar (cinacalcet) 60mg tablets in 30-count bottles due to Current Good Manufacturing Practice (CGMP) deviations. The affected product, NDC 55513-074-30, was manufactured in Japan and distributed from California.
This affects Amgen, Inc., as well as logistics, quality, and pharmacy personnel involved in the distribution and inventory management of Sensipar 60mg tablets.
Current Good Manufacturing Practice (CGMP) deviations suggest potential lapses in the manufacturing process, quality control, or facility standards. A Class II designation indicates that while the product may cause temporary or medically reversible adverse health consequences, the probability of serious harm is remote. This recall highlights the importance of oversight for international manufacturing sites.
QA and Supply Chain teams should verify inventory for NDC 55513-074-30 and initiate internal holds if necessary. Manufacturing units should review recent audit findings related to Japanese fabrication sites to identify potential systemic CGMP gaps.
Class II. Reason: CGMP Deviations. Product: Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-074-30. Firm: Amgen, Inc. (Thousand Oaks CA United States). Status: Ongoing.
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