D-0650-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 14, 2021
- Initiation Date
- June 9, 2021
- Termination Date
- August 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