FDA recall D-0650-2021

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

Reason for recall

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

Distribution

Product was distributed nationwide

Key facts

Status

Terminated

Initiation date

2021-06-09

Report date

2021-07-14

Termination date

2022-08-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

South San Francisco, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0650-2021