{
  "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": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA077627"
        ],
        "brand_name": [
          "TOPIRAMATE"
        ],
        "generic_name": [
          "TOPIRAMATE"
        ],
        "manufacturer_name": [
          "Glenmark Pharmaceuticals Inc., USA"
        ],
        "product_ndc": [
          "68462-108",
          "68462-153",
          "68462-109",
          "68462-110"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TOPIRAMATE"
        ],
        "rxcui": [
          "151226",
          "199888",
          "199889",
          "199890"
        ],
        "spl_id": [
          "2068fcde-8e47-4ced-a038-b00c04dcceb8"
        ],
        "spl_set_id": [
          "35312f49-decf-428d-bf5f-4215b762ed3c"
        ],
        "package_ndc": [
          "68462-108-60",
          "68462-108-05",
          "68462-108-10",
          "68462-153-60",
          "68462-153-05",
          "68462-153-10",
          "68462-109-60",
          "68462-109-05",
          "68462-109-10",
          "68462-110-60",
          "68462-110-05",
          "68462-110-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368462109601",
          "0368462153604",
          "0368462110607"
        ],
        "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": "64995",
      "recalling_firm": "Glenmark Generics 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-331-2013",
      "product_description": "Glenmark Topiramate Tablets, 200 mg,  60-count bottle, (NDC 68462-110-60), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for :  Glenmark Generics USA Mahwah, NJ 07430",
      "product_quantity": "9624 bottles",
      "reason_for_recall": "Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.",
      "recall_initiation_date": "20130405",
      "center_classification_date": "20130516",
      "termination_date": "20141009",
      "report_date": "20130522",
      "code_info": "Lot# 02123782, Exp 11/14",
      "more_code_info": ""
    }
  ]
}