{
  "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": "Hasbrouck Heights",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA090170"
        ],
        "brand_name": [
          "LAMOTRIGINE"
        ],
        "generic_name": [
          "LAMOTRIGINE"
        ],
        "manufacturer_name": [
          "Unichem Pharmaceuticals (USA), Inc."
        ],
        "product_ndc": [
          "29300-111",
          "29300-112",
          "29300-113",
          "29300-114"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LAMOTRIGINE"
        ],
        "rxcui": [
          "198427",
          "198428",
          "198429",
          "282401"
        ],
        "spl_id": [
          "03f59daf-b60e-46d1-b121-6a39361ee4f3"
        ],
        "spl_set_id": [
          "4b72ea7a-a0b0-4980-84ad-84f64e2e6368"
        ],
        "package_ndc": [
          "29300-111-01",
          "29300-111-05",
          "29300-111-10",
          "29300-112-01",
          "29300-112-05",
          "29300-112-10",
          "29300-113-16",
          "29300-113-05",
          "29300-113-10",
          "29300-114-16",
          "29300-114-05",
          "29300-114-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0329300113167",
          "0329300111019",
          "0329300114164"
        ],
        "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": "75205",
      "recalling_firm": "Unichem Pharmaceuticals Usa Inc",
      "address_1": "777 Terrace Ave",
      "address_2": "Suite 102",
      "postal_code": "07604-3102",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1519-2016",
      "product_description": "Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only,  Manufactured by: Unichem Laboratories LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511 India; Marketed by: Unichem Pharmaceuticals (USA), Inc ., Rochelle Park, NJ 07662; NDC 29300-113-05.",
      "product_quantity": "368 bottles",
      "reason_for_recall": "Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.",
      "recall_initiation_date": "20160819",
      "center_classification_date": "20160923",
      "termination_date": "20170207",
      "report_date": "20161005",
      "code_info": "Lot #: GLEH 16003, Exp 03/31/18"
    }
  ]
}