{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Bridgewater",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA020449"
        ],
        "brand_name": [
          "DOCETAXEL"
        ],
        "generic_name": [
          "DOCETAXEL"
        ],
        "manufacturer_name": [
          "Sanofi-Aventis U.S. LLC"
        ],
        "product_ndc": [
          "0955-1020",
          "0955-1021",
          "0955-1022"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "DOCETAXEL"
        ],
        "rxcui": [
          "1860480",
          "1860485",
          "1861411"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        "package_ndc": [
          "0955-1021-04",
          "0955-1020-01",
          "0955-1022-08"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "15H5577CQD"
        ]
      },
      "product_type": "Drugs",
      "event_id": "79964",
      "recalling_firm": "Sanofi-Aventis U.S. LLC",
      "address_1": "55 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "08807-1265",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US nationwide",
      "recall_number": "D-0804-2018",
      "product_description": "Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC 0955-1020-01",
      "product_quantity": "19580 vials",
      "reason_for_recall": "Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.",
      "recall_initiation_date": "20180427",
      "center_classification_date": "20180514",
      "termination_date": "20210120",
      "report_date": "20180509",
      "code_info": "Lot #: 7F307A, 7F307C, Exp 01/2019"
    }
  ]
}