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Recall Observatory FDA recall evidence

Drug 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

D-1177-2023

August 22, 2023

Class II

Product summary

Firm
Sofie Co dba Sofie
Event
Event 93073
Status
Terminated
Classification
Class II
Quantity
6 patient doses
Official record key
drug-enforcement:D-1177-2023

Official wording

Reason: Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).

Code information: Batch # FBBVA123082201, EOS: 22 Aug 2023/08:25, EXP: 22 Aug 2023/18:25

Distribution pattern: Product was released to one facility in VA.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out-of-specification
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility