Genentech Inc recalls Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. Single-Dose Prefilled Sy
Recalled July 14, 2021 · FDA recall D-0650-2021 · Genentech
Hazard
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point. · FDA Class II
Units
88,620 prefilled syringes
Sold at
Product was distributed nationwide
Description
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
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
Manufacturer(s)
Genentech Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →