XOLAIR

Cardinal Health Inc. has initiated a Class II recall for four units of Genentech's Xolair (omalizumab) due to temperature excursions, indicating CGMP deviations. This incident highlights persistent cold chain vulnerabilities within Cardinal Health's distribution network, following similar recalls for XIGDUO XR and RECOMBINATE. Procurement and supply chain leaders must reassess third-party logistics risks for temperature-sensitive biologics.

Cardinal Health Inc. has initiated a Class II recall for Genentech's Xolair (omalizumab injection) due to critical temperature excursions during storage. This event, involving 6 units, highlights persistent cold chain vulnerabilities within Cardinal Health's distribution network. For procurement and regulatory leaders, this underscores the imperative for stringent cold chain audits and diversified supplier strategies to safeguard sensitive biologic supply and ensure patient safety.