{
  "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": "69479",
      "recalling_firm": "Pfizer Inc.",
      "address_1": "235 East 42nd Street",
      "address_2": "N/A",
      "postal_code": "10017-5703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-0235-2015",
      "product_description": "TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL and 1 vial of 2.2 mL DILUENT per carton, Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101; Diluent \u0013 MADE IN ITALY; NDC 0008-1179-01.",
      "product_quantity": "16,000 kits",
      "reason_for_recall": "Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage. The TORISEL vials are not affected by this issue.",
      "recall_initiation_date": "20141010",
      "center_classification_date": "20141104",
      "termination_date": "20170414",
      "report_date": "20141112",
      "code_info": "Kit Lot #: AIEM/13, Exp 05/16 that contain diluent lots AHZW/11 and AHZW/12"
    }
  ]
}