{
  "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": [
          "ANDA076131"
        ],
        "brand_name": [
          "PACLITAXEL"
        ],
        "generic_name": [
          "PACLITAXEL"
        ],
        "manufacturer_name": [
          "Hospira, Inc."
        ],
        "product_ndc": [
          "61703-015",
          "61703-342"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "PACLITAXEL"
        ],
        "rxcui": [
          "312199"
        ],
        "spl_id": [
          "f4f04a49-a3f6-40cd-b261-aa889a0b7d0d"
        ],
        "spl_set_id": [
          "ea28753a-8631-460a-bfdc-b101eb8ac84a"
        ],
        "package_ndc": [
          "61703-342-09",
          "61703-342-22",
          "61703-342-50",
          "61703-015-04"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175085",
          "N0000175592"
        ],
        "pharm_class_pe": [
          "Microtubule Inhibition [PE]"
        ],
        "pharm_class_epc": [
          "Microtubule Inhibitor [EPC]"
        ],
        "unii": [
          "P88XT4IS4D"
        ]
      },
      "product_type": "Drugs",
      "event_id": "62459",
      "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, including Puerto Rico and Guam.    Product was also distributed internationally to Australia, Belgium, Canada, France, Germany, Korea, Malaysia, New Zealand, Norway, Pakistan, Philippines, Portugal, Singapore, Sweden, Thailand and  Vietnam",
      "recall_number": "D-1682-2012",
      "product_description": "Paclitaxel Injection, 6 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; N DC 61703-342-50",
      "product_quantity": "131,264 vials",
      "reason_for_recall": "The affected lots of Carboplatin Injection, Cytarabine  Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.",
      "recall_initiation_date": "20120627",
      "center_classification_date": "20120919",
      "termination_date": "20161215",
      "report_date": "20120926",
      "code_info": "lot numbers Y096865AA, exp AUG 2013; Y106865AA, exp AUG 2013; Y116865AA, exp AUG 2013; Y126865AA, exp SEP 2013; Y136865AA, exp SEP 2013; Y146865AA, exp SEP 2013; Y156865AA, exp OCT 2013; Y166865AA, exp NOV 2013; Y176865AA, exp NOV 2013; and Y186865AA, exp DEC 2013",
      "more_code_info": ""
    }
  ]
}