{
  "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": "Hawthorne",
      "state": "NY",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA074649"
        ],
        "brand_name": [
          "CARBAMAZEPINE"
        ],
        "generic_name": [
          "CARBAMAZEPINE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "51672-4005",
          "51672-4041",
          "51672-4050",
          "51672-4123",
          "51672-4124",
          "51672-4125",
          "51672-4047"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CARBAMAZEPINE"
        ],
        "rxcui": [
          "197442",
          "199378",
          "308973",
          "308976",
          "308979",
          "402505",
          "402506"
        ],
        "spl_id": [
          "48fd19fc-5d5b-0d24-e063-6294a90a0aa0"
        ],
        "spl_set_id": [
          "0526a054-3eda-49b4-b390-7d5d16e30af8"
        ],
        "package_ndc": [
          "51672-4041-1",
          "51672-4041-2",
          "51672-4041-9",
          "51672-4041-0",
          "51672-4050-1",
          "51672-4005-1",
          "51672-4005-2",
          "51672-4005-3",
          "51672-4123-6",
          "51672-4123-1",
          "51672-4123-3",
          "51672-4124-6",
          "51672-4124-1",
          "51672-4124-3",
          "51672-4125-6",
          "51672-4125-1",
          "51672-4125-3",
          "51672-4047-9",
          "51672-4047-4"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0351672405014",
          "0351672412418",
          "0351672404741"
        ],
        "nui": [
          "N0000008486",
          "N0000175751",
          "N0000185506",
          "N0000191266",
          "N0000187064",
          "N0000185507",
          "N0000185607"
        ],
        "pharm_class_pe": [
          "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
        ],
        "pharm_class_epc": [
          "Mood Stabilizer [EPC]"
        ],
        "pharm_class_moa": [
          "Cytochrome P450 3A4 Inducers [MoA]",
          "Cytochrome P450 1A2 Inducers [MoA]",
          "Cytochrome P450 2B6 Inducers [MoA]",
          "Cytochrome P450 2C9 Inducers [MoA]",
          "Cytochrome P450 2C19 Inducers [MoA]"
        ],
        "unii": [
          "33CM23913M"
        ]
      },
      "product_type": "Drugs",
      "event_id": "69413",
      "recalling_firm": "Taro Pharmaceuticals U.S.A., Inc.",
      "address_1": "3 Skyline Dr",
      "address_2": "N/A",
      "postal_code": "10532-2174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "IL, OH, LA",
      "recall_number": "D-0049-2015",
      "product_description": "Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 26110 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4005-3.",
      "product_quantity": "1,966 bottles",
      "reason_for_recall": "Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system.  An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval.",
      "recall_initiation_date": "20141021",
      "center_classification_date": "20141027",
      "termination_date": "20170403",
      "report_date": "20141105",
      "code_info": "Lot 137393, exp. 10/2016",
      "more_code_info": ""
    }
  ]
}