REGULATORY INTELLIGENCE·Recall
Cardinal Health Inc. Faces FDA Class II Recall for XIGDUO XR Due to Storage Temperature Excursions
Cardinal Health Inc. faced a Class II recall for 664 bottles of XIGDUO XR (dapagliflozin/metformin HCl) due to CGMP deviations involving temperature excursions during storage across Florida, Georgia, and South Carolina. This terminated 2024-06-17 recall underscores the critical need for robust temperature control in pharmaceutical distribution, impacting supply chain integrity and regulatory compliance for all stakeholders.
90-Day Activity