D-1177-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 4, 2023
- Initiation Date
- August 22, 2023
- Termination Date
- December 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 patient doses
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).
Distribution Pattern
Product was released to one facility in VA.
Code Information
Batch # FBBVA123082201, EOS: 22 Aug 2023/08:25, EXP: 22 Aug 2023/18:25