{
  "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": "2026-07-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA209538"
        ],
        "brand_name": [
          "PERAMPANEL"
        ],
        "generic_name": [
          "PERAMPANEL"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "51672-4204",
          "51672-4205",
          "51672-4206",
          "51672-4207",
          "51672-4208",
          "51672-4209"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PERAMPANEL"
        ],
        "rxcui": [
          "1356557",
          "1356570",
          "1356574",
          "1356578",
          "1356582",
          "1356586"
        ],
        "spl_id": [
          "4653e298-d84f-dc92-e063-6294a90a2d75"
        ],
        "spl_set_id": [
          "1b0458ea-e718-4d48-ae55-ad9b4d863810"
        ],
        "package_ndc": [
          "51672-4205-6",
          "51672-4205-2",
          "51672-4204-6",
          "51672-4204-3",
          "51672-4206-6",
          "51672-4206-2",
          "51672-4207-6",
          "51672-4207-2",
          "51672-4208-6",
          "51672-4208-2",
          "51672-4209-6",
          "51672-4209-2"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0351672420567",
          "0351672420666",
          "0351672420765",
          "0351672420963",
          "0351672420468"
        ],
        "nui": [
          "N0000186106",
          "N0000020016",
          "N0000191273",
          "N0000191278",
          "N0000182141",
          "N0000187062"
        ],
        "pharm_class_epc": [
          "Noncompetitive AMPA Glutamate Receptor Antagonist [EPC]"
        ],
        "pharm_class_moa": [
          "AMPA Receptor Antagonists [MoA]",
          "UGT2B7 Inhibitors [MoA]",
          "UGT1A9 Inhibitors [MoA]",
          "Cytochrome P450 3A4 Inhibitors [MoA]",
          "Cytochrome P450 2C8 Inhibitors [MoA]"
        ],
        "unii": [
          "H821664NPK"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99256",
      "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 in the USA",
      "recall_number": "D-0628-2026",
      "product_description": "Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 51672-4206-6",
      "product_quantity": "3,456 30-count bottles",
      "reason_for_recall": "Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.",
      "recall_initiation_date": "20260617",
      "center_classification_date": "20260626",
      "report_date": "20260701",
      "code_info": "Lot AE01763, Expires 9/30/2027."
    }
  ]
}