{
  "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": "Marlborough",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA018956"
        ],
        "brand_name": [
          "OMNIPAQUE"
        ],
        "generic_name": [
          "IOHEXOL"
        ],
        "manufacturer_name": [
          "GE Healthcare Inc."
        ],
        "product_ndc": [
          "0407-1401",
          "0407-1411",
          "0407-1412",
          "0407-1413",
          "0407-1414",
          "0407-1415",
          "0407-1416"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVASCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "IOHEXOL"
        ],
        "spl_id": [
          "5bd452ab-2645-4f2d-8f53-2e984ee231b4"
        ],
        "spl_set_id": [
          "eee15ebe-d349-4497-acef-6abe7a8247fb"
        ],
        "package_ndc": [
          "0407-1401-52",
          "0407-1411-10",
          "0407-1411-20",
          "0407-1412-10",
          "0407-1412-20",
          "0407-1412-50",
          "0407-1412-29",
          "0407-1412-30",
          "0407-1412-60",
          "0407-1412-33",
          "0407-1412-27",
          "0407-1412-49",
          "0407-1412-34",
          "0407-1412-28",
          "0407-1412-35",
          "0407-1413-11",
          "0407-1413-10",
          "0407-1413-59",
          "0407-1413-30",
          "0407-1413-50",
          "0407-1413-51",
          "0407-1413-61",
          "0407-1413-95",
          "0407-1413-98",
          "0407-1413-62",
          "0407-1413-99",
          "0407-1413-60",
          "0407-1413-63",
          "0407-1413-91",
          "0407-1413-53",
          "0407-1413-90",
          "0407-1413-65",
          "0407-1413-92",
          "0407-1413-66",
          "0407-1413-93",
          "0407-1413-96",
          "0407-1413-69",
          "0407-1414-21",
          "0407-1414-50",
          "0407-1414-51",
          "0407-1414-52",
          "0407-1414-89",
          "0407-1414-20",
          "0407-1414-90",
          "0407-1414-22",
          "0407-1414-53",
          "0407-1414-60",
          "0407-1414-91",
          "0407-1414-76",
          "0407-1414-03",
          "0407-1414-23",
          "0407-1414-93",
          "0407-1414-04",
          "0407-1414-94",
          "0407-1414-24",
          "0407-1414-80",
          "0407-1414-95",
          "0407-1415-09",
          "0407-1416-12"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000180185",
          "N0000010258"
        ],
        "pharm_class_epc": [
          "Radiographic Contrast Agent [EPC]"
        ],
        "pharm_class_moa": [
          "X-Ray Contrast Activity [MoA]"
        ],
        "unii": [
          "4419T9MX03"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81691",
      "recalling_firm": "GE Healthcare Inc. Life Sciences",
      "address_1": "100 Results Way",
      "address_2": "",
      "postal_code": "01752-3078",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "TN",
      "recall_number": "D-0319-2019",
      "product_description": "Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial, packaged in 10 x 20 mL Vials per carton, Rx only, Distributed by GE Healthcare Inc., Marlborough, MA 01752 U.S.A.; Manufactured by GE Healthcare AS, Oslo, Norway; NDC 0407-1411-20.",
      "product_quantity": "1092 cartons",
      "reason_for_recall": "Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance and/or the potential for glass particles.",
      "recall_initiation_date": "20181029",
      "center_classification_date": "20181214",
      "termination_date": "20231030",
      "report_date": "20181226",
      "code_info": "Lot #: 14301544, Exp 21Sep21",
      "more_code_info": ""
    }
  ]
}