Genentech Inc: Drug Recall

Recall #D-0650-2021 · 06/09/2021

Class II: Risk

Recall Details

Recall Number: D-0650-2021
Classification: Class II
Product Type: Drug
Recalling Firm: Genentech Inc
Status: Terminated
Date Initiated: 06/09/2021
Location: South San Francisco, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 88,620 prefilled syringes

Reason for Recall

Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.

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

Distribution Pattern

Product was distributed nationwide

Other Recalls by Genentech Inc

Class II: Risk 05/20/2024

Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Class III: Low Risk 10/18/2022

Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.
Class III: Low Risk 04/20/2021

Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.

View all recalls by Genentech Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.