{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA205467"
        ],
        "brand_name": [
          "FEBUXOSTAT"
        ],
        "generic_name": [
          "FEBUXOSTAT"
        ],
        "manufacturer_name": [
          "NorthStar RxLLC"
        ],
        "product_ndc": [
          "16714-059",
          "16714-060"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FEBUXOSTAT"
        ],
        "rxcui": [
          "834235",
          "834241"
        ],
        "spl_id": [
          "0284b7a5-7a1f-4e37-9883-b7bdba68c42b"
        ],
        "spl_set_id": [
          "ad40e0f6-850c-429a-87fc-f1eb2361e962"
        ],
        "package_ndc": [
          "16714-059-01",
          "16714-060-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0316714060019"
        ],
        "nui": [
          "N0000175698",
          "N0000000206"
        ],
        "pharm_class_epc": [
          "Xanthine Oxidase Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Xanthine Oxidase Inhibitors [MoA]"
        ],
        "unii": [
          "101V0R1N2E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94142",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "N/A",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0369-2024",
      "product_description": "Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-060-01.",
      "product_quantity": "7,488 bottles",
      "reason_for_recall": "CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.",
      "recall_initiation_date": "20240304",
      "center_classification_date": "20240308",
      "report_date": "20240320",
      "code_info": "Lot #: DNE0894A, Exp 07/31/2025"
    }
  ]
}