Drug product
Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
D-0572-2025
Product summary
- Event
- Event 97360
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4 units
- Official record key
drug-enforcement:D-0572-2025
Official wording
Reason: CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Code information: Lot: 3630004, Expires: 10/31/2025.
Distribution pattern: Nationwide Within the U.S.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations