{
  "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": "2026-08-05",
    "results": {
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  "results": [
    {
      "status": "Terminated",
      "city": "Hawthorne",
      "state": "NY",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA078525"
        ],
        "brand_name": [
          "LAMOTRIGINE"
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        "generic_name": [
          "LAMOTRIGINE"
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        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
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          "51672-4131",
          "51672-4132",
          "51672-4133"
        ],
        "product_type": [
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        "route": [
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        "substance_name": [
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        "rxcui": [
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          "282401"
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        "spl_id": [
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        "spl_set_id": [
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          "51672-4133-0"
        ],
        "is_original_packager": [
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        "upc": [
          "0351672413019",
          "0351672413347",
          "0351672413248",
          "0351672413118"
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          "N0000008486",
          "N0000175751",
          "N0000187061",
          "N0000000191"
        ],
        "pharm_class_epc": [
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          "Mood Stabilizer [EPC]"
        ],
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        ],
        "pharm_class_moa": [
          "Organic Cation Transporter 2 Inhibitors [MoA]",
          "Dihydrofolate Reductase Inhibitors [MoA]"
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        "unii": [
          "U3H27498KS"
        ]
      },
      "product_type": "Drugs",
      "event_id": "84645",
      "recalling_firm": "Taro Pharmaceuticals U.S.A., Inc.",
      "address_1": "3 Skyline Dr",
      "address_2": "",
      "postal_code": "10532-2174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the U.S. and Puerto Rico.",
      "recall_number": "D-0833-2020",
      "product_description": "Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle,  Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4131-1.",
      "product_quantity": "",
      "reason_for_recall": "Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.",
      "recall_initiation_date": "20191220",
      "center_classification_date": "20200207",
      "termination_date": "20240223",
      "report_date": "20200219",
      "code_info": "Lot #: 331771, Exp. June 2021",
      "more_code_info": ""
    }
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}