{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Princeton",
      "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": [
          "5359bc3e-4d59-7b7a-e063-6394a90a70c5"
        ],
        "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": "91311",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0085-2023",
      "product_description": "Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13), c)1000-count bottles (NDC 62756-185-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India.",
      "product_quantity": "Lot HAC1474A: 4296 Bottles, Lot HAC1474B: 145 Bottles, Lot HAC1503A: 2124 Bottles",
      "reason_for_recall": "Presence of foreign substance",
      "recall_initiation_date": "20221201",
      "center_classification_date": "20221219",
      "termination_date": "20230913",
      "report_date": "20221228",
      "code_info": "a) Lot HAC1474A, Expires 03/2023 b) Lot HAC1503A, Expires 03/2023 c) Lot HAC1474B, Expires 03/2023",
      "more_code_info": ""
    }
  ]
}