{
  "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 III",
      "openfda": {
        "application_number": [
          "ANDA076517"
        ],
        "brand_name": [
          "CARBOPLATIN"
        ],
        "generic_name": [
          "CARBOPLATIN"
        ],
        "manufacturer_name": [
          "Hospira, Inc."
        ],
        "product_ndc": [
          "61703-339",
          "61703-150",
          "61703-360",
          "61703-262",
          "61703-600"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "CARBOPLATIN"
        ],
        "rxcui": [
          "597195"
        ],
        "spl_id": [
          "0ddf4411-7138-412a-908a-fadf22bdfb79",
          "5aa72c15-8033-4559-b257-373371b18958"
        ],
        "spl_set_id": [
          "c3ae9880-44bb-4f4e-93d8-8a5e21708a30",
          "47677091-fd20-49af-933c-c9dd2be21de9"
        ],
        "package_ndc": [
          "61703-339-18",
          "61703-339-22",
          "61703-339-50",
          "61703-339-56",
          "61703-360-18",
          "61703-150-05",
          "61703-262-05",
          "61703-600-05",
          "61703-360-50"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175413",
          "N0000175073"
        ],
        "pharm_class_epc": [
          "Platinum-based Drug [EPC]"
        ],
        "unii": [
          "BG3F62OND5"
        ]
      },
      "product_type": "Drugs",
      "event_id": "62463",
      "recalling_firm": "Hospira Inc.",
      "address_1": "275 N Field Dr",
      "address_2": "",
      "postal_code": "60045-2579",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-1648-2012",
      "product_description": "Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) (NDC 61703-360-18, NOVAPLUS),  b) 45 mL multi-dose vials (NDC 61703-339-50) (NDC 61703-360-50 NOVAPLUS), Rx only, Hospira, Inc., Lake Forest, IL 60045, Product of Australia",
      "product_quantity": "77,542 vials",
      "reason_for_recall": "Failed PH specification:  The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.",
      "recall_initiation_date": "20120702",
      "center_classification_date": "20120816",
      "termination_date": "20170724",
      "report_date": "20120822",
      "code_info": "5 mL vial - NDC 61703-339-18 (Hospira label), lot number Y031654AB, expiration APR2013; NDC 61703-360-18 (Novoplus label), lot number Y031654AA, expiration APR2013;   45 mL vial - NDC 61703-339-50 (Hospira label), lot numbers Y041711AA, expiration DEC 2012 and Y061711AB, expiration FEB 2013; NDC 61703-360-50 (Novoplus label), lot number Y061711AA, expiration FEB 2013",
      "more_code_info": ""
    }
  ]
}