{
  "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,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA018963"
        ],
        "brand_name": [
          "CHOLETEC"
        ],
        "generic_name": [
          "MEBROFENIN"
        ],
        "manufacturer_name": [
          "Bracco Diagnostics Inc"
        ],
        "product_ndc": [
          "0270-0083"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "MEBROFENIN"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
          "fd085485-998d-42a3-879a-b2d96cb8aed7"
        ],
        "package_ndc": [
          "0270-0083-20"
        ],
        "is_original_packager": [
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        ],
        "unii": [
          "7PV0B6ED98"
        ]
      },
      "product_type": "Drugs",
      "event_id": "63535",
      "recalling_firm": "Bracco Diagnostic Inc",
      "address_1": "107 College Rd E",
      "address_2": "",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide.",
      "recall_number": "D-095-2013",
      "product_description": "Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive, Diagnostic Use, For Intravenous Use, Multidose, Rx Only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ  08543, by Hollister-Stier Laboratories LLC, Spokane Washington 99207, NDC 0270-0083-20.",
      "product_quantity": "196,280 Vials",
      "reason_for_recall": "Presence of Particulate Matter; potential for charcoal particulates",
      "recall_initiation_date": "20120814",
      "center_classification_date": "20121219",
      "termination_date": "20130906",
      "report_date": "20121226",
      "code_info": "Lot #s:  C0672, Exp 09/30/2012; C0689, Exp 10/31/2012; C0723, Exp 12/31/2012; C0799, Exp 02/28/2013; C0852, Exp 05/31/2013.",
      "more_code_info": ""
    }
  ]
}