{
  "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": "Cranbury",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA203263"
        ],
        "brand_name": [
          "DOXORUBICIN HYDROCHLORIDE"
        ],
        "generic_name": [
          "DOXORUBICIN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "47335-049",
          "47335-050"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "DOXORUBICIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "1790115",
          "1790127"
        ],
        "spl_id": [
          "dc7b9af1-bb7c-45f8-8f2e-d03c6e22898e"
        ],
        "spl_set_id": [
          "fbc48fa5-0bfb-4957-b13c-a56bb7a13b56"
        ],
        "package_ndc": [
          "47335-049-40",
          "47335-050-40"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0347335050400"
        ],
        "unii": [
          "82F2G7BL4E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78947",
      "recalling_firm": "Sun Pharmaceutical Industries, Inc.",
      "address_1": "270 Prospect Plains Rd",
      "address_2": "N/A",
      "postal_code": "08512-3605",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed nationwide in the USA",
      "recall_number": "D-0229-2018",
      "product_description": "DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use Vial, Distributed by: Sun Pharmaceutical Industries , Inc. Cranbury, NJ 08512. Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway. Halol-389 350, Gujarat, India. NDC 47335-049-40",
      "product_quantity": "393 vials",
      "reason_for_recall": "Lack Of Assurance Of Sterility",
      "recall_initiation_date": "20180116",
      "center_classification_date": "20180119",
      "termination_date": "20180914",
      "report_date": "20180131",
      "code_info": "Lot # JKS0403A Exp 02/2019"
    }
  ]
}