{
  "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": "New York",
      "state": "NY",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA022088"
        ],
        "brand_name": [
          "TORISEL"
        ],
        "generic_name": [
          "TEMSIROLIMUS"
        ],
        "manufacturer_name": [
          "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc."
        ],
        "product_ndc": [
          "0008-1179"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "rxcui": [
          "722289",
          "725108"
        ],
        "spl_id": [
          "8731b3b1-29d9-46b1-a443-822d8057f773"
        ],
        "spl_set_id": [
          "95b7dc92-2180-42f1-8699-3c28f609e674"
        ],
        "package_ndc": [
          "0008-1179-01",
          "0008-1279-01",
          "0008-1125-01"
        ],
        "is_original_packager": [
          true
        ]
      },
      "product_type": "Drugs",
      "event_id": "64690",
      "recalling_firm": "Pfizer Inc.",
      "address_1": "235 East 42nd Street",
      "address_2": "",
      "postal_code": "10017-5703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-219-2013",
      "product_description": "TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED, Rx Only,  Packaged in a carton containing 1 vial TORISEL injection and 1 vial DILUENT for TORISEL, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA --- NDC 0008-1179-01",
      "product_quantity": "10920 kits",
      "reason_for_recall": "Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.",
      "recall_initiation_date": "20121126",
      "center_classification_date": "20130326",
      "termination_date": "20150331",
      "report_date": "20130403",
      "code_info": "Lots P00025A; P00027B",
      "more_code_info": ""
    }
  ]
}