{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Dublin",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA205253"
        ],
        "brand_name": [
          "TRAZODONE HYDROCHLORIDE"
        ],
        "generic_name": [
          "TRAZODONE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Major Pharmaceuticals"
        ],
        "product_ndc": [
          "0904-6868",
          "0904-6869",
          "0904-7212"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TRAZODONE HYDROCHLORIDE"
        ],
        "rxcui": [
          "856364",
          "856373",
          "856377"
        ],
        "spl_id": [
          "1bfc986d-82a1-4503-8eea-7ebf3186d09d"
        ],
        "spl_set_id": [
          "8eb85c26-a6cb-4a10-a990-ccc0b20aff08"
        ],
        "package_ndc": [
          "0904-6868-61",
          "0904-6869-61",
          "0904-7212-61"
        ],
        "original_packager_product_ndc": [
          "68382-805",
          "68382-806",
          "68382-807"
        ],
        "unii": [
          "6E8ZO8LRNM"
        ]
      },
      "product_type": "Drugs",
      "event_id": "87512",
      "recalling_firm": "Cardinal Health Inc.",
      "address_1": "7000 Cardinal Pl",
      "address_2": "N/A",
      "postal_code": "43017-1091",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "FL, GA, SC",
      "recall_number": "D-0510-2021",
      "product_description": "TRAZODONE HYDROCHLORIDE TABLETS, USP 50MG 100 TABLET 10X10UD; NDC/UPC 0904-6868-61; RX; TABLETS",
      "product_quantity": "91 CARTON",
      "reason_for_recall": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
      "recall_initiation_date": "20210315",
      "center_classification_date": "20210524",
      "termination_date": "20240617",
      "report_date": "20210602",
      "code_info": "R01580"
    }
  ]
}