{
  "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": "Livonia",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA075712"
        ],
        "brand_name": [
          "CARBAMAZEPINE"
        ],
        "generic_name": [
          "CARBAMAZEPINE"
        ],
        "manufacturer_name": [
          "Major Pharmaceuticals"
        ],
        "product_ndc": [
          "0904-3854",
          "0904-6172"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CARBAMAZEPINE"
        ],
        "rxcui": [
          "308973",
          "308979"
        ],
        "spl_id": [
          "15db121f-16b4-4723-83d3-94a31337f922"
        ],
        "spl_set_id": [
          "2a8c7366-ce89-47ce-8123-96f26812fca0"
        ],
        "package_ndc": [
          "0904-3854-61",
          "0904-3854-80",
          "0904-6172-61",
          "0904-6172-50"
        ],
        "original_packager_product_ndc": [
          "13668-271",
          "13668-268"
        ],
        "upc": [
          "0309043854800"
        ],
        "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": "88583",
      "recalling_firm": "The Harvard Drug Group",
      "address_1": "17187 N Laurel Park Dr Ste 300",
      "address_2": "",
      "postal_code": "48152-2600",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "NC",
      "recall_number": "D-0807-2021",
      "product_description": "Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd., Bharuch-392130, India; Manufactured for: Torrent Pharma, Inc., Basking Ridge, NJ 07920; Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA.  NDC 0904-6172-61",
      "product_quantity": "4 Cartons of 100 count each",
      "reason_for_recall": "Failed Dissolution Specifications",
      "recall_initiation_date": "20210806",
      "center_classification_date": "20210917",
      "termination_date": "20221108",
      "report_date": "20210929",
      "code_info": "Lot R01562; Exp. 10/2022",
      "more_code_info": ""
    }
  ]
}