Drug recall D-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
Reason for recall
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Lots and codes
Lot No.: 3352758, Exp. Date Aug 2021; Lot No.: 3352759, Exp. Date Aug 2021
Recall details
- Recalling firm
- Genentech Inc, South San Francisco, CA
- Quantity
- 88,620 prefilled syringes
- Distribution
- Product was distributed nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 9, 2021
- Terminated
- August 11, 2022
Related products
- Xolair – drug information
- NDC 50242-040 Xolair · Omalizumab 150 mg/1.2mL · Genentech, Inc.
- NDC 50242-227 Xolair · Omalizumab 300 mg/2mL · Genentech, Inc.
- NDC 50242-215 Xolair PFS · Omalizumab 150 mg/mL · Genentech, Inc.
- NDC 50242-214 Xolair PFS · Omalizumab 75 mg/.5mL · Genentech, Inc.