{
  "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": "Terminated",
      "city": "Wilmington",
      "state": "MA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA214679"
        ],
        "brand_name": [
          "EPRONTIA"
        ],
        "generic_name": [
          "TOPIRAMATE"
        ],
        "manufacturer_name": [
          "Azurity Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "52652-9001"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TOPIRAMATE"
        ],
        "rxcui": [
          "2586427",
          "2586433"
        ],
        "spl_id": [
          "3feb6452-372c-4c60-8e91-220be75f90b1"
        ],
        "spl_set_id": [
          "e2a4df59-fead-4a01-9021-9eda02c48010"
        ],
        "package_ndc": [
          "52652-9001-1",
          "52652-9001-2",
          "52652-9001-3"
        ],
        "is_original_packager": [
          true
        ],
        "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": "93552",
      "recalling_firm": "Azurity Pharmaceuticals, Inc.",
      "address_1": "841 Woburn St",
      "address_2": "N/A",
      "postal_code": "01887-3414",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA nationwide.",
      "recall_number": "D-0213-2024",
      "product_description": "Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1",
      "product_quantity": "2,220 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.",
      "recall_initiation_date": "20231208",
      "center_classification_date": "20240102",
      "termination_date": "20240424",
      "report_date": "20240110",
      "code_info": "Lot #: MB22020B, Exp 12/27/2023"
    }
  ]
}