REGULATORY INTELLIGENCE·Recall
Amgen's Neupogen Filgrastim Recall: Global Supply Chain Implications Due to Stability Issues
Amgen, Inc. has initiated a Class II recall for 313,620 vials of Neupogen (filgrastim) globally, citing stability data that fails to support the product's 36-month expiry. This voluntary action, impacting diverse markets from the U.S. to Europe and Asia, poses significant supply chain risks for procurement and regulatory teams reliant on Amgen's leukocyte growth factor. Stakeholders must assess inventory and explore alternative filgrastim sources to mitigate potential disruptions.
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