Status
Ongoing
Drug Enforcement D-0571-2025
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Classification
Class II
Report Date
August 13, 2025
Termination Date
—
Product Information
- Product description
- Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
- Product quantity
- 6 units
- Reason for recall
- CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide Within the U.S.
Location & Firm
- Recalling firm
- Cardinal Health Inc.
- Address
-
7000 Cardinal Pl, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0571-2025
- Event ID
- 97360
- Recall initiation date
- July 30, 2025
- Center classification date
- August 7, 2025
- Code info
- Lot: 3617756, Expires: 12/31/2025.
- More code info
- —