Data Composite

Recall D-0571-2025

US Class II Ongoing · initiated 2025-07-30

Recalling firm

Cardinal Health Inc., OH

Product

Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.

Reason for recall

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

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