{
  "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": "North Chicago",
      "state": "IL",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA020478"
        ],
        "brand_name": [
          "ULTANE"
        ],
        "generic_name": [
          "SEVOFLURANE"
        ],
        "manufacturer_name": [
          "AbbVie Inc."
        ],
        "product_ndc": [
          "0074-4456"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "RESPIRATORY (INHALATION)"
        ],
        "substance_name": [
          "SEVOFLURANE"
        ],
        "rxcui": [
          "200243",
          "541963"
        ],
        "spl_id": [
          "4b7ba14d-8de1-4f87-910e-87fdd984b24d"
        ],
        "spl_set_id": [
          "c9aa6489-5a36-44ed-9512-b996833d82f7"
        ],
        "package_ndc": [
          "0074-4456-51"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175975",
          "N0000175681"
        ],
        "pharm_class_pe": [
          "General Anesthesia [PE]"
        ],
        "pharm_class_epc": [
          "General Anesthetic [EPC]"
        ],
        "unii": [
          "38LVP0K73A"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78969",
      "recalling_firm": "AbbVie Inc.",
      "address_1": "1 N Waukegan Rd",
      "address_2": "",
      "postal_code": "60064-1802",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "MS, OH",
      "recall_number": "D-0412-2018",
      "product_description": "Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by:  AbbVie Inc., North Chicago, IL 60064, USA. NDC 0074-4456-51",
      "product_quantity": "7,770 bottles",
      "reason_for_recall": "Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.",
      "recall_initiation_date": "20180122",
      "center_classification_date": "20180209",
      "termination_date": "20180913",
      "report_date": "20180207",
      "code_info": "Lot #: 1088856, Exp 6/20",
      "more_code_info": ""
    }
  ]
}