{
  "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": "2026-08-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Raleigh",
      "state": "NC",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "NDA020923"
        ],
        "brand_name": [
          "OPTIRAY"
        ],
        "generic_name": [
          "IOVERSOL"
        ],
        "manufacturer_name": [
          "Liebel-Flarsheim Company LLC"
        ],
        "product_ndc": [
          "0019-1323",
          "0019-1333",
          "0019-1332"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRA-ARTERIAL",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "IOVERSOL"
        ],
        "spl_id": [
          "471b778f-d9cc-ff10-e063-6394a90a27c9"
        ],
        "spl_set_id": [
          "cd718d1c-f813-4114-a50d-c744ff7eb1bf"
        ],
        "package_ndc": [
          "0019-1333-65",
          "0019-1323-65",
          "0019-1332-65"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0300191332653",
          "0300191323651",
          "0300191333650"
        ],
        "nui": [
          "N0000180185",
          "N0000010258"
        ],
        "pharm_class_epc": [
          "Radiographic Contrast Agent [EPC]"
        ],
        "pharm_class_moa": [
          "X-Ray Contrast Activity [MoA]"
        ],
        "unii": [
          "N3RIB7X24K"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99510",
      "recalling_firm": "Liebel-Flarsheim Company LLC",
      "address_1": "8800 Durant Rd",
      "address_2": "",
      "postal_code": "27616-3104",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Distributed Nationwide in the US and Mexico.",
      "recall_number": "D-0773-2026",
      "product_description": "Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Made in USA, NDC 0019-1333-65.",
      "product_quantity": "3,486 500mL-vials",
      "reason_for_recall": "Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.",
      "recall_initiation_date": "20260731",
      "center_classification_date": "20260819",
      "report_date": "20260819",
      "code_info": "Lot # 25ZF3670, Exp Date: May 31, 2027.",
      "more_code_info": ""
    }
  ]
}