REGULATORY INTELLIGENCE·Recall
AstraZeneca's Airsupra Inhalation Aerosol Faces FDA Class II Recall Over Defective Delivery System
AstraZeneca Pharmaceuticals LP has initiated a voluntary Class II recall (D-0444-2025) for over one million units of Airsupra (albuterol and budesonide) inhalation aerosol due to a defective delivery system. This nationwide U.S. distribution recall, impacting critical respiratory therapy, necessitates immediate supply chain reassessment and robust quality control for combination products.
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