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Denosumab

FDA recalls

2 rows

DateCompany and reasonClass
Apr 20, 2025McKesson Medical-Surgical Inc. Corporate Office
CGMP Deviations; potential temperature excursions due to transit delays
Class II · Ongoing
Sep 16, 2013Amgen, Inc.
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
Class II · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).