Reported Jul 14, 2021 · Terminated
Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. Single-Dose Prefilled…
Genentech Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Genentech Inc · 1 Dna Way · South San Francisco, CA · 94080-4918
Is this the product you have?
- Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. Single-Dose Prefilled Syringe. Product of France
- Manufactured byGenentech, Inc. A Member of the Roche Group, South San Francisco, CA 9480-4990
- NDC50242-215-01
- Lot codes and dates
Lot No.: 3352758Exp. Date Aug 2021Lot No.: 3352759Exp. Date Aug 2021
- Amount recalled
- 88,620 prefilled syringes
Where it was sold
- Nationwide
Why it was recalled
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
This product could cause temporary or reversible health problems — stop using it.
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