{
  "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": "2026-06-03",
    "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": [
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          "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",
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          "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",
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          "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-0447-2026",
      "product_description": "GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.",
      "product_quantity": "866,570 vials",
      "reason_for_recall": "Presence of particulate matter",
      "recall_initiation_date": "20260324",
      "center_classification_date": "20260409",
      "report_date": "20260415",
      "code_info": "Lot# 17225029; Exp. September 3, 2028 Lot# 17265376; Exp. October 3, 2028 Lot# 17270885; Exp. September 10, 2028 Lot# 17292246; Exp. October 4, 2028 Lot# 17301805; Exp. October 18, 2028 Lot# 17301807; Exp. September 7, 2028 Lot# 17301810; Exp. October 20, 2028 Lot# 17304992; Exp. October 5, 2028 Lot# 17304993; Exp. October 19, 2028 Lot# 17304996; Exp. November 25, 2028 Lot# 17321225; Exp. September 8, 2028 Lot# 17333589; Exp. November 24, 2028 Lot# 17333611; Exp. November 26. 2028 Lot# 17333613; Exp. November 23. 2028 Lot# 17357000; Exp. December 5, 2028 Lot# 17366399; Exp. December 14, 2028 Lot# 17376486; Exp. December 14, 2028 Lot# 17404114; Exp. December 6, 2028",
      "more_code_info": ""
    }
  ]
}