Recalls / Class II
Class IID-1177-2023
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
- Brand name
- Neuraceq
- Generic name
- Florbetaben F 18
- Active ingredient
- Florbetaben F-18
- Route
- Intravenous
- NDC
- 54828-001
- FDA application
- NDA204677
- Affected lot / code info
- Batch # FBBVA123082201, EOS: 22 Aug 2023/08:25, EXP: 22 Aug 2023/18:25
Why it was recalled
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
Recalling firm
- Firm
- Sofie Co dba Sofie
- Manufacturer
- Lantheus Biosciences Ltd.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 100 Executive Dr Ste 6, N/A, Sterling, Virginia 20166-9507
Distribution
- Quantity
- 6 patient doses
- Distribution pattern
- Product was released to one facility in VA.
Timeline
- Recall initiated
- 2023-08-22
- FDA classified
- 2023-09-26
- Posted by FDA
- 2023-10-04
- Terminated
- 2023-12-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1177-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.