{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Lake Forest",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077548"
        ],
        "brand_name": [
          "ONDANSETRON"
        ],
        "generic_name": [
          "ONDANSETRON"
        ],
        "manufacturer_name": [
          "Hospira, Inc."
        ],
        "product_ndc": [
          "0409-4755",
          "0409-4759"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "ONDANSETRON HYDROCHLORIDE"
        ],
        "rxcui": [
          "283504",
          "1740467"
        ],
        "spl_id": [
          "f4d4b538-f4fd-49d7-ac02-b72d48c52e59"
        ],
        "spl_set_id": [
          "6a11f61b-2318-4382-2b91-4366e4bb53fa"
        ],
        "package_ndc": [
          "0409-4755-18",
          "0409-4755-03",
          "0409-4759-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "NMH84OZK2B"
        ]
      },
      "product_type": "Drugs",
      "event_id": "65300",
      "recalling_firm": "Hospira, Inc.",
      "address_1": "600 N Field Dr Bldg J45",
      "address_2": "N/A",
      "postal_code": "60045",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-851-2013",
      "product_description": "Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-03, Hospira, Inc, Lake Forest, IL 60045.",
      "product_quantity": "340,600 vials",
      "reason_for_recall": "Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot",
      "recall_initiation_date": "20130520",
      "center_classification_date": "20130807",
      "termination_date": "20141028",
      "report_date": "20130814",
      "code_info": "Lot 25394DK, exp. 01/2015"
    }
  ]
}