{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Pulaski",
      "state": "TN",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA079132"
        ],
        "brand_name": [
          "LAMOTRIGINE"
        ],
        "generic_name": [
          "LAMOTRIGINE"
        ],
        "manufacturer_name": [
          "AvKARE"
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        "product_ndc": [
          "42291-366",
          "42291-367",
          "42291-368",
          "42291-369"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
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        "substance_name": [
          "LAMOTRIGINE"
        ],
        "rxcui": [
          "198427",
          "198428",
          "198429",
          "282401"
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        "spl_id": [
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        "spl_set_id": [
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        "package_ndc": [
          "42291-366-01",
          "42291-366-10",
          "42291-367-01",
          "42291-367-10",
          "42291-368-60",
          "42291-368-50",
          "42291-369-60",
          "42291-369-50"
        ],
        "original_packager_product_ndc": [
          "59746-245",
          "59746-246",
          "59746-247",
          "59746-248"
        ],
        "upc": [
          "0342291368606",
          "342291367104"
        ],
        "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": "90637",
      "recalling_firm": "AVKARE Inc.",
      "address_1": "615 N 1st St",
      "address_2": "",
      "postal_code": "38478-2403",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-1329-2022",
      "product_description": "Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4",
      "product_quantity": "8328 bottles",
      "reason_for_recall": "Labeling: Label Error on Declared Strength",
      "recall_initiation_date": "20220720",
      "center_classification_date": "20220808",
      "termination_date": "20240930",
      "report_date": "20220817",
      "code_info": "Lot #: 42581 Exp. 12/2024; 42484 Exp. 11/2024; 41204 Exp. 05/2024; 38723 Exp. 02/2023; 37623 Exp. 10/2022",
      "more_code_info": ""
    }
  ]
}