Florbetaben F-18 Injection Solution 1 recalled over sterility concerns

Recall date

August 22, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Sofie Co dba Sofie recalls Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vial, Diagnostic-For Int…

Recall number

D-1177-2023

FDA classification

Class II

Brand / firm

Sofie Co dba Sofie

Sold / distributed

Product was released to one facility in VA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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