FDA recall D-0855-2022

Amgen, Inc. · Class II · drug

Product

MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution, 100 mg/4 ml, Single dose vial, Rx only, Manufactured by Amgen Inc. Thousand Oaks, CA 91320-1799, NDC 55513-0206-01

Reason for recall

Defective container: loose crimp defect, potential loss of container integrity.

Distribution

Nationwide in the USA, Egypt and Lithuania.

Key facts

Status: Terminated
Initiation date: 2022-05-02
Report date: 2022-05-18
Termination date: 2022-12-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Thousand Oaks, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0855-2022