Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vi...
FDA Recall #D-1177-2023 — Class II — August 22, 2023
Product Description
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).
Recalling Firm
Sofie Co dba Sofie — Sterling, VA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
6 patient doses
Distribution
Product was released to one facility in VA.
Code Information
Batch # FBBVA123082201, EOS: 22 Aug 2023/08:25, EXP: 22 Aug 2023/18:25
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated