Drug recall D-0572-2025
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.
Lots and codes
Lot: 3630004, Expires: 10/31/2025.
Recall details
- Recalling firm
- Cardinal Health Inc., Dublin, OH
- Quantity
- 4 units
- Distribution
- Nationwide Within the U.S.
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 30, 2025
Related products
- Xolair – drug information
- NDC 50242-215 Xolair PFS · Omalizumab 150 mg/mL · Genentech, Inc.
- NDC 50242-040 Xolair · Omalizumab 150 mg/1.2mL · Genentech, Inc.
- NDC 50242-214 Xolair PFS · Omalizumab 75 mg/.5mL · Genentech, Inc.
- NDC 50242-227 Xolair · Omalizumab 300 mg/2mL · Genentech, Inc.