Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Genentech, Inc. | Oceanside, CA, United States | Makes the active ingredient and tests it | No problems foundAug 16, 2024 · 5 inspections |
| Genentech, Inc. | South San Francisco, CA, United States | Tests it | No problems foundMay 15, 2026 · 37 inspections |
Recalls
- Jul 30, 2025 · Class II · Cardinal Health Inc.
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Lots: Lot: 3617756, Expires: 12/31/2025. - Jul 30, 2025 · Class II · Cardinal Health Inc.
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Lots: Lot: 3630004, Expires: 10/31/2025. - Jun 9, 2021 · Class II · Genentech Inc
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Lots: Lot No.: 3352758, Exp. Date Aug 2021; Lot No.: 3352759, Exp. Date Aug 2021
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Omalizumab: every company that makes it
- Form
- injection, solution, subcutaneous
- Strength
- 300 mg per 2 mL
- Approval
- BLA BLA103976
- On the market since
- Aug 18, 2023
- Package NDCs
50242-227-0150242-227-5550242-227-8650242-227-99- Official label
- DailyMed (National Library of Medicine), updated Aug 13, 2026
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