Recall D-0572-2025

US Class II Ongoing · initiated 2025-07-30

Recalling firm

Cardinal Health Inc., OH

Product

Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55

Reason for recall

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

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