FDA recall D-1177-2023

Product

Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vial, Diagnostic-For Intravenous Use Only, Manufactured by SOFIE Co dba SOFIE, Dulles, VA 20166 for Life Molecular Imagining Ltd., NDC 54828-001-50

Reason for recall

Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).

Distribution

Product was released to one facility in VA.

Key facts

Status

Terminated

Initiation date

2023-08-22

Report date

2023-10-04

Termination date

2023-12-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sterling, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1177-2023