FDAHealthJuly 30, 2025
Cardinal Health Inc. — Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
⚠️ CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 30, 2025
Nationwide Within the U.S.
What's affected?
- Product
- Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
- Brand
- XOLAIR
- Lot code
- 3630004
Additional details
Lot: 3630004, Expires: 10/31/2025.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 4 units.
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