Sterling, VA, United States
Sofie Co dba Sofie recalls
1 recall recorded since 2018, most recently on 22 August 2023. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 22 August 2023
- Terminated
- 4 December 2023
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1177-2023
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.