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Recall Observatory FDA recall evidence

Drug product

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

D-0572-2025

July 30, 2025

Class II

Product summary

Firm
Cardinal Health Inc.
Event
Event 97360
Status
Ongoing
Classification
Class II
Quantity
4 units
Official record key
drug-enforcement:D-0572-2025

Official wording

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

Code information: Lot: 3630004, Expires: 10/31/2025.

Distribution pattern: Nationwide Within the U.S.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations