D-0650-2021 Class II Terminated
FDA drug recall D-0650-2021 was initiated by Genentech Inc on Jun 9, 2021 and is designated Class II. Reason for recall: Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point. The recall status is terminated (terminated Aug 11, 2022). Affected quantity: 88,620 prefilled syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 14, 2021
- Initiation Date
- Jun 9, 2021
- Termination Date
- Aug 11, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 88,620 prefilled syringes
Product Description
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.
Distribution Pattern
Product was distributed nationwide
Code Information
Lot No.: 3352758, Exp. Date Aug 2021; Lot No.: 3352759, Exp. Date Aug 2021
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0650-2021
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026