{
  "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": "Cranbury",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077794"
        ],
        "brand_name": [
          "OXCARBAZEPINE"
        ],
        "generic_name": [
          "OXCARBAZEPINE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "62756-183",
          "62756-184",
          "62756-185"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "OXCARBAZEPINE"
        ],
        "rxcui": [
          "312136",
          "312137",
          "312138"
        ],
        "spl_id": [
          "56aeed00-02fa-483d-b4be-45362e10f5ff"
        ],
        "spl_set_id": [
          "7ecd5eef-46f4-407f-9b63-ba65adb3eced"
        ],
        "package_ndc": [
          "62756-183-83",
          "62756-183-88",
          "62756-183-08",
          "62756-183-13",
          "62756-183-18",
          "62756-184-83",
          "62756-184-88",
          "62756-184-08",
          "62756-184-13",
          "62756-184-18",
          "62756-185-83",
          "62756-185-88",
          "62756-185-08",
          "62756-185-13",
          "62756-185-18"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0362756183834",
          "0362756185838",
          "0362756184831"
        ],
        "nui": [
          "N0000175753",
          "N0000008486"
        ],
        "pharm_class_epc": [
          "Anti-epileptic Agent [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
        ],
        "unii": [
          "VZI5B1W380"
        ]
      },
      "product_type": "Drugs",
      "event_id": "67426",
      "recalling_firm": "Caraco Pharmaceutical Laboratories Ltd.",
      "address_1": "270 Prospect Plains Rd",
      "address_2": "N/A",
      "postal_code": "08512-3605",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1081-2014",
      "product_description": "Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only.  Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijiah McCoy Drive, Detroit, MI, 48202.  Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.  NDC 62756-184-88,    Rx only, 100 Tablets; Pharmacist: Dispense the Medication Guide provided separately to each patient.   Each film-coated tablet contains 300 mg oxcarbazepine, USP, Usual Dosage:  See package insert, Dispense in tight container (USP) tore at 25 C (77 F) excursions permitted....  Distributed by Caraco Pharmaceuticals Detroit, MI....",
      "product_quantity": "7005 bottles",
      "reason_for_recall": "Failed Tablet Specifications: Broken Tablets Present.",
      "recall_initiation_date": "20140129",
      "center_classification_date": "20140210",
      "termination_date": "20140929",
      "report_date": "20140219",
      "code_info": "Lot #: JKM7075A, Expiry:10/15"
    }
  ]
}