{
  "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 I",
      "openfda": {
        "application_number": [
          "ANDA076871"
        ],
        "brand_name": [
          "MITOXANTRONE"
        ],
        "generic_name": [
          "MITOXANTRONE"
        ],
        "manufacturer_name": [
          "Hospira, Inc."
        ],
        "product_ndc": [
          "61703-343"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "MITOXANTRONE HYDROCHLORIDE"
        ],
        "rxcui": [
          "197989"
        ],
        "spl_id": [
          "8658f2e1-ad36-4ce0-af12-80814bd8bf5c"
        ],
        "spl_set_id": [
          "accf9569-4b57-4e83-a7db-4e890a75d1ba"
        ],
        "package_ndc": [
          "61703-343-18",
          "61703-343-65",
          "61703-343-66"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "U6USW86RD0"
        ]
      },
      "product_type": "Drugs",
      "event_id": "70064",
      "recalling_firm": "Hospira Inc.",
      "address_1": "275 N Field Dr",
      "address_2": "N/A",
      "postal_code": "60045-2579",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US: Nationwide including Puerto Rico; Australia, Canada, Cyprus, Egypt, Ireland, Saudi Arabia, Qatar, Oman, Bahrain, and United Kingdom.",
      "recall_number": "D-0433-2015",
      "product_description": "MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only.  Hospira, Lake Forest, IL 60045, Product of Australia. Available in a) 20 mg/10 mL Multi Dose Vial (NDC: 61703-343-18); b) 25 mg/12.5 mL Multi Dose Vial (NDC: 61703-343-65); c) 30 mg/15 mL Multi Dose Vial (NDC: 61703-343-66).",
      "product_quantity": "13,792 Vials (U.S.)",
      "reason_for_recall": "Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.",
      "recall_initiation_date": "20141203",
      "center_classification_date": "20150406",
      "termination_date": "20161202",
      "report_date": "20150415",
      "code_info": "LOTS DISTRIBUTED IN THE UNITED STATES:    a) Lot: Z054636AA, Expiry: December 2014; Lot: A014636AA, Expiry: April 2015; Lot: A024636AB, Expiry: July 2015. b) Lot: A014645AA, Expiry: November 2015.  c)  Lot: A014643AA, Expiry April 2015."
    }
  ]
}