Drug recall D-0571-2025
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.
Lots and codes
Lot: 3617756, Expires: 12/31/2025.
Recall details
- Recalling firm
- Cardinal Health Inc., Dublin, OH
- Quantity
- 6 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.