Status
Terminated
Drug Enforcement D-1177-2023
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
Classification
Class II
Report Date
October 4, 2023
Termination Date
December 4, 2023
Product Information
- 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
- Product quantity
- 6 patient doses
- Reason for recall
- Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Product was released to one facility in VA.
Location & Firm
- Recalling firm
- Sofie Co dba Sofie
- Address
-
100 Executive Dr Ste 6, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1177-2023
- Event ID
- 93073
- Recall initiation date
- August 22, 2023
- Center classification date
- September 26, 2023
- Code info
- Batch # FBBVA123082201, EOS: 22 Aug 2023/08:25, EXP: 22 Aug 2023/18:25
- More code info
- —