D-0571-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- August 13, 2025
- Initiation Date
- July 30, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
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.
Distribution Pattern
Nationwide Within the U.S.
Code Information
Lot: 3617756, Expires: 12/31/2025.