{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Completed",
      "city": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077651"
        ],
        "brand_name": [
          "ZONISAMIDE"
        ],
        "generic_name": [
          "ZONISAMIDE"
        ],
        "manufacturer_name": [
          "Glenmark Pharmaceuticals Inc., USA"
        ],
        "product_ndc": [
          "68462-128",
          "68462-129",
          "68462-130"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ZONISAMIDE"
        ],
        "rxcui": [
          "314285",
          "403966",
          "403967"
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        "spl_id": [
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        ],
        "spl_set_id": [
          "fe15e56e-8b86-4a65-825c-31d37dd81612"
        ],
        "package_ndc": [
          "68462-128-01",
          "68462-128-05",
          "68462-129-01",
          "68462-129-05",
          "68462-130-01",
          "68462-130-05"
        ],
        "is_original_packager": [
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        "upc": [
          "0368462130018",
          "0368462129012",
          "0368462128015"
        ],
        "nui": [
          "N0000175753",
          "N0000008486",
          "M0020790",
          "N0000000235",
          "N0000185503"
        ],
        "pharm_class_epc": [
          "Anti-epileptic Agent [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
        ],
        "pharm_class_cs": [
          "Sulfonamides [CS]"
        ],
        "pharm_class_moa": [
          "Carbonic Anhydrase Inhibitors [MoA]",
          "P-Glycoprotein Inhibitors [MoA]"
        ],
        "unii": [
          "459384H98V"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90029",
      "recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
      "address_1": "750 Corporate Dr",
      "address_2": "",
      "postal_code": "07430-2009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA nationwide",
      "recall_number": "D-0793-2022",
      "product_description": "Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430",
      "product_quantity": "a) 7,044 bottles; b) 1,014 bottles",
      "reason_for_recall": "cGMP deviations",
      "recall_initiation_date": "20220425",
      "center_classification_date": "20220427",
      "report_date": "20220504",
      "code_info": "a) Lot #: 29200053, Exp 4/30/2023; b) Lot #: 29200054, Exp 4/30/2023",
      "more_code_info": ""
    }
  ]
}