REGULATORY INTELLIGENCE·Recall
FDA Class II Recall: Inadvertent Distribution of Pfizer-Distributed Inflectra (Infliximab-dyyb) Due to cGMP Deviation
McKesson initiated a Class II recall (D-0213-2025) for 192 vials of Pfizer-distributed Inflectra (infliximab-dyyb) due to cGMP deviations, specifically inadvertent distribution of quarantined product. This event highlights critical vulnerabilities in supply chain quality control and segregation protocols, demanding immediate attention from procurement and regulatory teams to assess internal and partner compliance.
90-Day Activity