Recalls / Class II
Class IID-0650-2021
Product
Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. Single-Dose Prefilled Syringe. Product of France, Manufactured by: Genentech, Inc. A Member of the Roche Group, South San Francisco, CA 9480-4990. NDC: 50242-215-01
- Brand name
- Xolair
- Generic name
- Omalizumab
- Active ingredient
- Omalizumab
- Route
- Subcutaneous
- NDCs
- 50242-040, 50242-214, 50242-215, 50242-227
- FDA application
- BLA103976
- Affected lot / code info
- Lot No.: 3352758, Exp. Date Aug 2021; Lot No.: 3352759, Exp. Date Aug 2021
Why it was recalled
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Recalling firm
- Firm
- Genentech Inc
- Manufacturer
- Genentech, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Dna Way, South San Francisco, California 94080-4918
Distribution
- Quantity
- 88,620 prefilled syringes
- Distribution pattern
- Product was distributed nationwide
Timeline
- Recall initiated
- 2021-06-09
- FDA classified
- 2021-07-06
- Posted by FDA
- 2021-07-14
- Terminated
- 2022-08-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0650-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.