{
  "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": "Rockville",
      "state": "MD",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA201635"
        ],
        "brand_name": [
          "TROKENDI XR"
        ],
        "generic_name": [
          "TOPIRAMATE"
        ],
        "manufacturer_name": [
          "Supernus Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "17772-101",
          "17772-102",
          "17772-103",
          "17772-104"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TOPIRAMATE"
        ],
        "rxcui": [
          "1436239",
          "1436245",
          "1437278",
          "1437280",
          "1437283",
          "1437285",
          "1437288",
          "1437290"
        ],
        "spl_id": [
          "4d7bcc14-c816-0b67-e063-6394a90a1097"
        ],
        "spl_set_id": [
          "2dc7957e-a3e5-46bb-aa66-f3250f872f5e"
        ],
        "package_ndc": [
          "17772-102-70",
          "17772-102-01",
          "17772-102-30",
          "17772-102-15",
          "17772-102-10",
          "17772-102-12",
          "17772-102-07",
          "17772-103-70",
          "17772-103-01",
          "17772-103-30",
          "17772-103-15",
          "17772-103-10",
          "17772-103-12",
          "17772-103-07",
          "17772-104-70",
          "17772-104-01",
          "17772-104-30",
          "17772-104-15",
          "17772-104-12",
          "17772-104-10",
          "17772-104-07",
          "17772-101-70",
          "17772-101-01",
          "17772-101-30",
          "17772-101-15",
          "17772-101-10",
          "17772-101-12",
          "17772-101-07"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0317772101300",
          "0317772102307",
          "0317772104301",
          "0317772103304"
        ],
        "nui": [
          "N0000008486",
          "N0000185506",
          "N0000182140"
        ],
        "pharm_class_pe": [
          "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
        ],
        "pharm_class_moa": [
          "Cytochrome P450 3A4 Inducers [MoA]",
          "Cytochrome P450 2C19 Inhibitors [MoA]"
        ],
        "unii": [
          "0H73WJJ391"
        ]
      },
      "product_type": "Drugs",
      "event_id": "74988",
      "recalling_firm": "Supernus Pharmaceuticals, Inc.",
      "address_1": "1550 E Gude Dr",
      "address_2": "N/A",
      "postal_code": "20850-1339",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0112-2017",
      "product_description": "Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850, NDC 17772-102-15",
      "product_quantity": "17,128 (30-count blister packs)",
      "reason_for_recall": "Superpotent Drug: Failure of assay specifications in the capsule.",
      "recall_initiation_date": "20160712",
      "center_classification_date": "20161020",
      "termination_date": "20190226",
      "report_date": "20161026",
      "code_info": "Lot # 426636, Exp 4/22/18"
    }
  ]
}