REGULATORY INTELLIGENCE·Recall
FDA Class II Recall: GlaxoSmithKline's BENLYSTA Impacted by Cold Chain Deviations
GlaxoSmithKline's BENLYSTA (belimumab) faces a Class II voluntary recall initiated by Mckesson Medical-Surgical Inc. due to CGMP deviations, specifically potential temperature excursions during transit. This event, affecting 3 vials distributed across OH, VA, and FL, underscores critical vulnerabilities in pharmaceutical cold chain logistics, demanding immediate attention from supply chain and regulatory leaders to safeguard product integrity and patient safety.
90-Day Activity