Sofie Co dba Sofie: Drug Recall
Recall #D-1177-2023 · 08/22/2023
Class II: Risk
Recall Details
- Recall Number
- D-1177-2023
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Sofie Co dba Sofie
- Status
- Terminated
- Date Initiated
- 08/22/2023
- Location
- Sterling, VA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 patient doses
Reason for Recall
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
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
Distribution Pattern
Product was released to one facility in VA.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.