{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA019414"
        ],
        "brand_name": [
          "CARDIOGEN-82"
        ],
        "generic_name": [
          "RUBIDIUM CHLORIDE RB-82"
        ],
        "manufacturer_name": [
          "Bracco Diagnostics Inc"
        ],
        "product_ndc": [
          "0270-0091"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "RUBIDIUM CHLORIDE RB-82"
        ],
        "spl_id": [
          "990b8a5b-d1f5-2119-1e01-cdccdcb607ba"
        ],
        "spl_set_id": [
          "ee95aa18-9f2f-40eb-9b4c-583bea6f36bf"
        ],
        "package_ndc": [
          "0270-0091-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "F0Z746KRKQ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "62866",
      "recalling_firm": "Bracco Diagnostics Inc",
      "address_1": "107 College Rd E",
      "address_2": "N/A",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and United Kingdom",
      "recall_number": "D-1684-2012",
      "product_description": "CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Medi-Physics, Inc. South Plainfield, NJ 07080, NDC 0270-0091-01",
      "product_quantity": "54 generators",
      "reason_for_recall": "GMP deviation; Sr-82 levels exceeded alert limit specification",
      "recall_initiation_date": "20120601",
      "center_classification_date": "20120921",
      "termination_date": "20130318",
      "report_date": "20121003",
      "code_info": "Lot numbers 09101-121251 and 09101-121391",
      "more_code_info": ""
    }
  ]
}