FDA-Drug2021-07-14Class II
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
Genentech Inc
Hazard
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Sold states
Product was distributed nationwide
Affected count
88,620 prefilled syringes
Manufactured in
1 Dna Way, South San Francisco, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0650-2021Don't want to check this manually?
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