{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Kalamazoo",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA203370"
        ],
        "brand_name": [
          "LAMOTRIGINE"
        ],
        "generic_name": [
          "LAMOTRIGINE"
        ],
        "manufacturer_name": [
          "Torrent Pharmaceuticals Limited"
        ],
        "product_ndc": [
          "13668-339",
          "13668-340",
          "13668-341",
          "13668-342"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LAMOTRIGINE"
        ],
        "rxcui": [
          "850087",
          "850091",
          "900156",
          "900164"
        ],
        "spl_id": [
          "aae9e98a-c9b3-4e3c-8e24-ff46f11bcadf"
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        "spl_set_id": [
          "52df02a7-83da-4b20-9951-69790237dc24"
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        "package_ndc": [
          "13668-339-30",
          "13668-339-01",
          "13668-339-05",
          "13668-340-30",
          "13668-340-01",
          "13668-340-05",
          "13668-341-30",
          "13668-341-01",
          "13668-341-05",
          "13668-342-30",
          "13668-342-01"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0313668342307",
          "0313668341300",
          "0313668340303"
        ],
        "nui": [
          "N0000175753",
          "N0000008486",
          "N0000175751",
          "N0000187061",
          "N0000000191"
        ],
        "pharm_class_epc": [
          "Anti-epileptic Agent [EPC]",
          "Mood Stabilizer [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
        ],
        "pharm_class_moa": [
          "Organic Cation Transporter 2 Inhibitors [MoA]",
          "Dihydrofolate Reductase Inhibitors [MoA]"
        ],
        "unii": [
          "U3H27498KS"
        ]
      },
      "product_type": "Drugs",
      "event_id": "80985",
      "recalling_firm": "Torrent Pharma Inc.",
      "address_1": "1803 Whites Rd Ste 1",
      "address_2": "N/A",
      "postal_code": "49008-2883",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide USA",
      "recall_number": "D-1204-2018",
      "product_description": "Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. NDC: 13668-342-30",
      "product_quantity": "15,384 30-count bottles",
      "reason_for_recall": "Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.",
      "recall_initiation_date": "20180911",
      "center_classification_date": "20180920",
      "termination_date": "20200904",
      "report_date": "20180926",
      "code_info": "Lot: BFR5D002 EXP 11-2019"
    }
  ]
}