{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Carrigtwohill",
      "state": "",
      "country": "Ireland",
      "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": [
          "61f3e388-89bf-43d6-ad51-b620fff561fb"
        ],
        "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": "98656",
      "recalling_firm": "GE Healthcare Ireland Limited",
      "address_1": "Ida Business Park",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "U.S. Nationwide.",
      "recall_number": "D-0448-2026",
      "product_description": "GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.",
      "product_quantity": "306,810 vials",
      "reason_for_recall": "Presence of particulate matter",
      "recall_initiation_date": "20260324",
      "center_classification_date": "20260409",
      "report_date": "20260415",
      "code_info": "Lot# 17333197; Exp. December 10, 2028 Lot# 17333198; Exp. November 17, 2028 Lot# 17396945; Exp. December 18, 2028 Lot# 17396948; Exp. December 22, 2028 Lot# 17396953; Exp. January 11, 2029 Lot# 17396956; Exp. January 9, 2029 Lot# 17423503; Exp. January 1, 2029 Lot# 17423525; Exp. January 3, 2029 Lot# 17426429; Exp. January 1, 2029 Lot# 17426440; Exp. January 4, 2029 Lot# 17431310; Exp. January 11, 2029",
      "more_code_info": ""
    }
  ]
}