Florbetaben F-18 — Class II drug recall D-1177-2023
Terminated recall by Sofie Co dba Sofie, reported 2023-10-04. Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
| Recall number | D-1177-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sofie Co dba Sofie, Sterling, VA, United States |
| Recall initiated | 2023-08-22 |
| Classified | 2023-09-26 |
| Reported by FDA | 2023-10-04 |
| Terminated | 2023-12-04 |
| Quantity | 6 patient |
| Reason classes | sterility |
| NDC | 54828-0001, 54828-0001-30, 54828-0001-50 |
| Lot numbers | FBBVA123082201 |
| Expiration dates | 2023-08-22 |
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 for recall
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1177-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.