{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA204193"
        ],
        "brand_name": [
          "DOCETAXEL"
        ],
        "generic_name": [
          "DOCETAXEL"
        ],
        "manufacturer_name": [
          "Dr. Reddy's Laboratories Inc."
        ],
        "product_ndc": [
          "43598-258",
          "43598-259",
          "43598-389"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "DOCETAXEL"
        ],
        "rxcui": [
          "1860480",
          "1860485",
          "1861411"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
          "a630937b-8369-74ad-b68a-f940eb16ff0f"
        ],
        "package_ndc": [
          "43598-258-11",
          "43598-259-40",
          "43598-389-57"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "15H5577CQD"
        ]
      },
      "product_type": "Drugs",
      "event_id": "82323",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "N/A",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-1001-2019",
      "product_description": "Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, Andhra Pradesh, INDIA, NDC 43598-259-40.",
      "product_quantity": "5,755 vials",
      "reason_for_recall": "Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.",
      "recall_initiation_date": "20190306",
      "center_classification_date": "20190312",
      "termination_date": "20220516",
      "report_date": "20190320",
      "code_info": "Lot#: H7081, Exp 07/2019"
    }
  ]
}