{
  "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": "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"
        ],
        "spl_id": [
          "c00ccc2d-52c6-4a11-a310-d8db25ca3928"
        ],
        "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": [
          true
        ],
        "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": "88591",
      "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": "Nationwide.",
      "recall_number": "D-0826-2021",
      "product_description": "Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Capsules NDC 68462-130-01; b) 500 Capsules NDC 68462-130-05",
      "product_quantity": "a) 216,454 bottles; b) 2166 bottles",
      "reason_for_recall": "CGMP Deviations",
      "recall_initiation_date": "20210827",
      "center_classification_date": "20210921",
      "termination_date": "20231004",
      "report_date": "20210929",
      "code_info": "Lots: a) 29200014 Exp. 02/28/2023; 29200015 Exp. 03/31/2023; 29200016 Exp. 03/31/2023; 29200030 Exp. 05/31/2023; 29200031 Exp. 05/31/2023; 29200032 Exp. 05/31/2023; 29200033 Exp. 06/30/2023; 29200037 Exp. 06/30/2023; 29200038 Exp. 06/30/2023; 29200039 Exp. 07/31/2023; 29200041 Exp. 07/31/2023; 29200042 Exp. 07/31/2023; 29200048 Exp. 08/31/2023; 29200049 Exp. 08/31/2023; 29200050 Exp. 08/31/2023; 29200072 Exp. 11/30/2023; 29200073 Exp. 11/30/2023; 29200074 Exp. 11/30/2023; 29200075 Exp. 11/30/2023; 29200076 Exp. 11/30/2023; b) 29200014 Exp. 02/28/2023; 29200015 Exp. 03/31/2023; 29200016 Exp. 03/31/2023",
      "more_code_info": ""
    }
  ]
}