REGULATORY INTELLIGENCE·Recall
GlaxoSmithKline Recalls ANORO ELLIPTA Due to Particle Size Issue: Implications for Respiratory Drug Supply
GlaxoSmithKline LLC initiated a Class III recall for 67,508 ANORO ELLIPTA inhalers from its Durham, NC facility due to out-of-specification coarse particle mass for umeclidinium. This event, now terminated, highlights critical quality control challenges in inhalation drug manufacturing. Procurement and supply chain leaders must reinforce quality oversight and diversification strategies for respiratory therapies to mitigate similar disruptions.
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