Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
Reported: August 13, 2025 Initiated: July 30, 2025 #D-0571-2025
Product Description
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.
Details
- Recalling Firm
- Cardinal Health Inc.
- Units Affected
- 6 units
- Distribution
- Nationwide Within the U.S.
- Location
- Dublin, OH
Frequently Asked Questions
What product was recalled? ▼
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.. Units affected: 6 units.
Why was this product recalled? ▼
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 13, 2025. Severity: Moderate. Recall number: D-0571-2025.
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