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
Reported: July 14, 2021 Initiated: June 9, 2021 #D-0650-2021
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.
Details
- Recalling Firm
- Genentech Inc
- Units Affected
- 88,620 prefilled syringes
- Distribution
- Product was distributed nationwide
- Location
- South San Francisco, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Genentech Inc. Units affected: 88,620 prefilled syringes.
Why was this product recalled? ▼
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 14, 2021. Severity: Moderate. Recall number: D-0650-2021.
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