Recall archive / FDA drug enforcement
Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vial, Diagnostic-For I... — FDA record D-1177-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 22, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
- Classification
- Class II
- Recalling firm
- Sofie Co dba Sofie
- Quantity
- 6 patient doses
- Agency-reported status
- Terminated
- Source record identifier
- D-1177-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Batch # FBBVA123082201, EOS: 22 Aug 2023/08:25, EXP: 22 Aug 2023/18:25 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Product was released to one facility in VA.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Oct 4, 2023
- Recall initiation date
- Aug 22, 2023
- Center classification date
- Sep 26, 2023
- Termination date
- Dec 4, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.