WhichRecall
Class IIReported 2025-08-13

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

Recalled by Cardinal Health Inc.

Reason for Recall

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

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Recall Number
D-0571-2025
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-07-30
Reported
2025-08-13
Distribution
Nationwide Within the U.S.
Code Info
Lot: 3617756, Expires: 12/31/2025.
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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