FDA Drug recall 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, M…
- FDA Drug
- Class II
- terminated
- Published 2023-10-04
On 2023-10-04 the FDA classified a Class II recall of 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, M… by Sofie, citing lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1177-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-08-22 |
| Published | 2023-10-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sofie |
| Distribution | VA |
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).
Identifiers
| ndc | 54828-001-30 |
|---|---|
| ndc | 54828-001-50 |
| code_info | Batch # FBBVA123082201, EOS: 22 Aug 2023/08:25, EXP: 22 Aug 2023/18:25 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1177-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.