REGULATORY INTELLIGENCE·Recall
McKesson Recalls Amgen's EVENITY Due to Cold Chain Failures: A Recurring Distribution Risk
McKesson Medical-Surgical Inc. is conducting a voluntary Class II recall of Amgen's EVENITY (romosozumab-aqqg) injection due to CGMP deviations and potential temperature excursions during transit. This event, affecting distribution in OH, VA, FL, signals recurring systemic issues in McKesson's cold chain integrity, following similar recalls in 2024. Procurement and regulatory teams must reassess distribution partner compliance to mitigate supply chain risks for temperature-sensitive biologics.
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