{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA217230"
        ],
        "brand_name": [
          "RUFINAMIDE"
        ],
        "generic_name": [
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        ],
        "manufacturer_name": [
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        ],
        "product_ndc": [
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          "59651-617"
        ],
        "product_type": [
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        ],
        "route": [
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        "substance_name": [
          "RUFINAMIDE"
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        "rxcui": [
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          "824301"
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        "spl_id": [
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        ],
        "spl_set_id": [
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        "package_ndc": [
          "59651-616-08",
          "59651-617-08"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0359651616086"
        ],
        "unii": [
          "WFW942PR79"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92756",
      "recalling_firm": "Aurobindo Pharma USA Inc.",
      "address_1": "279 Princeton Hightstown Rd",
      "address_2": "N/A",
      "postal_code": "08520-1401",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA nationwide",
      "recall_number": "D-1088-2023",
      "product_description": "Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by:  Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-617-08",
      "product_quantity": "48 bottles",
      "reason_for_recall": "cGMP deviations: Batch was released prior to approval.",
      "recall_initiation_date": "20230721",
      "center_classification_date": "20230818",
      "termination_date": "20240226",
      "report_date": "20230830",
      "code_info": "Lot #: RB4023002A, Exp 02/2025"
    }
  ]
}