{
  "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": "Completed",
      "city": "Lake Forest",
      "state": "IL",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA076517"
        ],
        "brand_name": [
          "CARBOPLATIN"
        ],
        "generic_name": [
          "CARBOPLATIN"
        ],
        "manufacturer_name": [
          "Hospira, Inc."
        ],
        "product_ndc": [
          "61703-339"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "CARBOPLATIN"
        ],
        "rxcui": [
          "597195"
        ],
        "spl_id": [
          "0ddf4411-7138-412a-908a-fadf22bdfb79"
        ],
        "spl_set_id": [
          "c3ae9880-44bb-4f4e-93d8-8a5e21708a30"
        ],
        "package_ndc": [
          "61703-339-18",
          "61703-339-22",
          "61703-339-50",
          "61703-339-56",
          "61703-360-50"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175413",
          "N0000175073"
        ],
        "pharm_class_epc": [
          "Platinum-based Drug [EPC]"
        ],
        "unii": [
          "BG3F62OND5"
        ]
      },
      "product_type": "Drugs",
      "event_id": "63548",
      "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": "Nationwide and Puerto Rico.",
      "recall_number": "D-154-2013",
      "product_description": "Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, NDC 61703-339-50 (Hospira label) and NDC 61703-360-50 (Novaplus label), Hospira, Inc., Lake Forest, IL 60045, Product of Australia.",
      "product_quantity": "31,326 vials",
      "reason_for_recall": "Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.",
      "recall_initiation_date": "20121108",
      "center_classification_date": "20130206",
      "termination_date": "20170320",
      "report_date": "20130213",
      "code_info": "lots Z011711AA (Hospira label) and Z011711AB (Novaplus label), Exp. 08/2013",
      "more_code_info": ""
    }
  ]
}