FDARecalled Aug 13, 2025 · #D-0572-2025
Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
Hazard
Class II — temporary health risk
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CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. Classification: Class II Distribution: Nationwide Within the U.S.
Product details
- Product
- Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
- Type
- Drugs
- Manufacturer
- Cardinal Health Inc.
- Model numbers
- 3630004
- UPCs
- —