D-1177-2023 Class II Terminated
FDA drug recall D-1177-2023 was initiated by Sofie Co Dba Sofie on Aug 22, 2023 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT). The recall status is terminated (terminated Dec 4, 2023). Affected quantity: 6 patient doses.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 4, 2023
- Initiation Date
- Aug 22, 2023
- Termination Date
- Dec 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1177-2023
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026