REGULATORY INTELLIGENCE·Recall
Cardinal Health Faces FDA Class II Recall for RECOMBINATE Due to Repeated Temperature Excursions
Cardinal Health Inc. has initiated a Class II recall for RECOMBINATE, Antihemophilic Factor (Recombinant), 5 mL vials, impacting three units nationwide. The recall, D-0573-2025, stems from CGMP deviations related to product exposure to temperatures outside labeled storage requirements. This marks a concerning pattern, as Cardinal Health faced a similar temperature excursion recall in 2021, signaling systemic cold chain vulnerabilities for procurement and supply chain leaders.
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