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FLORBETABEN F-18 Recall D-1177-2023

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

FLORBETABEN F-18 Recall D-1177-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-1177-2023
Event ID93073
Generic NameFLORBETABEN F 18
ManufacturerFLORBETABEN F 18
Original Package?1
Active SubstanceFLORBETABEN F-18
DistributionProduct was released to one facility in VA.
Quantity6 patient doses
Recall ReasonLack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
Drug ClassificationClass II
Drug Code Info20231004
Product NDC54828-001
Product NUIN0000177914 N0000175869
Pharma Class (EPC)Radioactive Diagnostic Agent [EPC]
Recall Initiation Date20230822
Report Date20231004
Classification Date20230926
Address100 Executive Dr Ste 6
Sterling, VA 20166-9507
United States
Recalling FirmSofie Co dba Sofie
Initial Notification Telephone
Unique Ingredient IdentifierTLA7312TOI
Drug Application NumberNDA204677
Structured Product Labeling (SPL ID)eb884bdb-3ff8-4765-8ee8-550a583c4bac
Structured Product Labeling (SPL Set ID)b0915068-cfd4-4d72-b9f8-7e31fe83cd1e
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