{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Basking Ridge",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077272"
        ],
        "brand_name": [
          "CARBAMAZEPINE"
        ],
        "generic_name": [
          "CARBAMAZEPINE"
        ],
        "manufacturer_name": [
          "Torrent Pharmaceuticals Limited"
        ],
        "product_ndc": [
          "13668-268",
          "13668-271"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CARBAMAZEPINE"
        ],
        "rxcui": [
          "308973",
          "308979"
        ],
        "spl_id": [
          "2b305f64-7c1a-4cf6-a4ad-57326eb4c874"
        ],
        "spl_set_id": [
          "97e6e175-75e8-437b-b457-ddb1ae4e857d"
        ],
        "package_ndc": [
          "13668-268-30",
          "13668-268-01",
          "13668-268-10",
          "13668-268-31",
          "13668-268-05",
          "13668-271-01",
          "13668-271-10",
          "13668-271-49",
          "13668-271-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0313668268300"
        ],
        "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": "89146",
      "recalling_firm": "Torrent Pharma Inc.",
      "address_1": "150 Allen Rd Ste 102",
      "address_2": "N/A",
      "postal_code": "07920-3856",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide USA",
      "recall_number": "D-0365-2022",
      "product_description": "Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd. Bharuch-392130, India Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920.",
      "product_quantity": "15,336 Bottles",
      "reason_for_recall": "Failed Dissolution Specifications",
      "recall_initiation_date": "20211202",
      "center_classification_date": "20220111",
      "termination_date": "20231023",
      "report_date": "20220119",
      "code_info": "Batch: 4J11G002 Exp. 08/2024"
    }
  ]
}