{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Sterling",
      "state": "VA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA204677"
        ],
        "brand_name": [
          "NEURACEQ"
        ],
        "generic_name": [
          "FLORBETABEN F 18"
        ],
        "manufacturer_name": [
          "Lantheus Biosciences Ltd., a Lantheus Company"
        ],
        "product_ndc": [
          "54828-001"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "FLORBETABEN F-18"
        ],
        "spl_id": [
          "54797009-949b-cdd1-e063-6294a90afaf4"
        ],
        "spl_set_id": [
          "b0915068-cfd4-4d72-b9f8-7e31fe83cd1e"
        ],
        "package_ndc": [
          "54828-001-30",
          "54828-001-50"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000177914",
          "N0000175869"
        ],
        "pharm_class_epc": [
          "Radioactive Diagnostic Agent [EPC]"
        ],
        "pharm_class_moa": [
          "Positron Emitting Activity [MoA]"
        ],
        "unii": [
          "TLA7312TOI"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93073",
      "recalling_firm": "Sofie Co dba Sofie",
      "address_1": "100 Executive Dr Ste 6",
      "address_2": "N/A",
      "postal_code": "20166-9507",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "Product was released to one facility in VA.",
      "recall_number": "D-1177-2023",
      "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_date": "20230822",
      "center_classification_date": "20230926",
      "termination_date": "20231204",
      "report_date": "20231004",
      "code_info": "Batch # FBBVA123082201, EOS: 22 Aug 2023/08:25, EXP: 22 Aug 2023/18:25"
    }
  ]
}