{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Boston",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA204333"
        ],
        "brand_name": [
          "FLUDEOXYGLUCOSE F 18"
        ],
        "generic_name": [
          "FLUDEOXYGLUCOSE F-18"
        ],
        "manufacturer_name": [
          "Massachusetts General Hospital"
        ],
        "product_ndc": [
          "76318-334"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "FLUDEOXYGLUCOSE F-18"
        ],
        "spl_id": [
          "d6019460-717e-4285-9582-06646e8f778a"
        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "76318-334-50"
        ],
        "is_original_packager": [
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        ],
        "nui": [
          "N0000177914",
          "N0000000205"
        ],
        "pharm_class_epc": [
          "Radioactive Diagnostic Agent [EPC]"
        ],
        "pharm_class_moa": [
          "Radiopharmaceutical Activity [MoA]"
        ],
        "unii": [
          "0Z5B2CJX4D"
        ]
      },
      "product_type": "Drugs",
      "event_id": "87384",
      "recalling_firm": "The General Hospital Corporation",
      "address_1": "55 Fruit St",
      "address_2": "N/A",
      "postal_code": "02114-2621",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "Product was distributed to one direct account.",
      "recall_number": "D-0288-2021",
      "product_description": "Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution, 50 mL glass vial, Rx only, Manufactured by Massachusetts General Hospital PET Center, Boston, MA  NDC 76318-334-50",
      "product_quantity": "50 mL vial",
      "reason_for_recall": "Lack of Assurance of Sterility",
      "recall_initiation_date": "20210217",
      "center_classification_date": "20210224",
      "termination_date": "20210326",
      "report_date": "20210303",
      "code_info": "Lot # P01-021721, exp 02/17/2021"
    }
  ]
}