{
  "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": "Completed",
      "city": "Montgomery",
      "state": "AL",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA022363"
        ],
        "brand_name": [
          "LIVALO"
        ],
        "generic_name": [
          "PITAVASTATIN CALCIUM"
        ],
        "manufacturer_name": [
          "Kowa Pharmaceuticals America, Inc."
        ],
        "product_ndc": [
          "66869-104",
          "66869-204",
          "66869-404"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PITAVASTATIN CALCIUM"
        ],
        "rxcui": [
          "861643",
          "861646",
          "861648",
          "861650",
          "861652",
          "861654"
        ],
        "spl_id": [
          "aacce141-185f-4d20-adb1-6cca3a9c87c4"
        ],
        "spl_set_id": [
          "44dcbf97-99ec-427c-ba50-207e0069d6d2"
        ],
        "package_ndc": [
          "66869-104-90",
          "66869-204-90",
          "66869-204-07",
          "66869-404-90",
          "66869-404-07"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0366869204905",
          "0366869404909",
          "0366869104908"
        ],
        "unii": [
          "IYD54XEG3W"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96379",
      "recalling_firm": "Kowa Pharmaceuticals America",
      "address_1": "530 Industrial Park Blvd",
      "address_2": "",
      "postal_code": "36117-5543",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "PA, OH, and TX",
      "recall_number": "D-0258-2025",
      "product_description": "Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd, Nagoya, 462-0024 Japan, Marketed by Kowa Pharmaceuticals: Kowa Pharmaceuticals America Inc., Montgomery, AL 36117 USA NDC 66869-404-90  HDPE Bottle, congregated into a shrink wrapped 6-pack further congregated into 24 6-packs in a cardboard case",
      "product_quantity": "5,328 Bottles",
      "reason_for_recall": "Presence of foreign tablets/capsules",
      "recall_initiation_date": "20250224",
      "center_classification_date": "20250307",
      "report_date": "20250319",
      "code_info": "Lot#: 3231300, Exp 8/2027",
      "more_code_info": ""
    }
  ]
}