{
  "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 Zurich",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076972"
        ],
        "brand_name": [
          "ONDANSETRON"
        ],
        "generic_name": [
          "ONDANSETRON HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "63323-373",
          "63323-374"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "ONDANSETRON HYDROCHLORIDE"
        ],
        "rxcui": [
          "283504",
          "1740467"
        ],
        "spl_id": [
          "83824969-e116-40d6-8940-ff134a4f16c0"
        ],
        "spl_set_id": [
          "e0050959-c14c-41b6-9a92-fadc5f6feff3"
        ],
        "package_ndc": [
          "63323-373-00",
          "63323-373-02",
          "63323-374-20"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363323374204",
          "0363323373009"
        ],
        "unii": [
          "NMH84OZK2B"
        ]
      },
      "product_type": "Drugs",
      "event_id": "63451",
      "recalling_firm": "Fresenius Kabi USA, LLC",
      "address_1": "3 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "60047-8930",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide Including Puerto Rico",
      "recall_number": "D-0296-2015",
      "product_description": "ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL),  For IM or IV Use, Single Dose 2 mL Vials, Rx only.  APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02",
      "product_quantity": "184,550 Vials",
      "reason_for_recall": "Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.",
      "recall_initiation_date": "20120927",
      "center_classification_date": "20141210",
      "termination_date": "20141212",
      "report_date": "20141217",
      "code_info": "Lot 6003930, exp. date 04/2014"
    }
  ]
}