Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
Reported: August 13, 2025 Initiated: July 30, 2025 #D-0572-2025
Product Description
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.
Details
- Recalling Firm
- Cardinal Health Inc.
- Units Affected
- 4 units
- Distribution
- Nationwide Within the U.S.
- Location
- Dublin, OH
Frequently Asked Questions
What product was recalled? ▼
Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55. Recalled by Cardinal Health Inc.. Units affected: 4 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-0572-2025.
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