{
  "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": "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": [
          "43598-610",
          "43598-611"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "DOCETAXEL"
        ],
        "rxcui": [
          "1860480",
          "1860485"
        ],
        "spl_id": [
          "948f7c4c-6a40-d240-3eb3-d9ae6e371429"
        ],
        "spl_set_id": [
          "be3df07d-ea56-453a-25ad-c3cedc22712a"
        ],
        "package_ndc": [
          "43598-611-11",
          "43598-610-40"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "15H5577CQD"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78842",
      "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": "Distributed nationwide in the USA, Uzbekistan, and Myanmar",
      "recall_number": "D-0213-2018",
      "product_description": "Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046 INDIA, NDC 43598-611-11",
      "product_quantity": "1,051 vials",
      "reason_for_recall": "Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is removed when the cap is flipped off.",
      "recall_initiation_date": "20170109",
      "center_classification_date": "20180112",
      "termination_date": "20181204",
      "report_date": "20180117",
      "code_info": "Lot #: H7044, Exp 05/19",
      "more_code_info": ""
    }
  ]
}