{
  "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": "Ann Arbor",
      "state": "MI",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA211617"
        ],
        "brand_name": [
          "NEXLIZET"
        ],
        "generic_name": [
          "BEMPEDOIC ACID AND EZETIMIBE"
        ],
        "manufacturer_name": [
          "Esperion Therapeutics, Inc."
        ],
        "product_ndc": [
          "72426-818"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BEMPEDOIC ACID",
          "EZETIMIBE"
        ],
        "rxcui": [
          "2283230",
          "2283236"
        ],
        "spl_id": [
          "29da37de-60f3-4dcc-8ccd-1b96631778bd"
        ],
        "spl_set_id": [
          "3fa2108c-0300-47b8-9d34-f762af7c93c6"
        ],
        "package_ndc": [
          "72426-818-03",
          "72426-818-99",
          "72426-818-09"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000193913",
          "N0000193914",
          "N0000008553",
          "N0000175911"
        ],
        "pharm_class_epc": [
          "Adenosine Triphosphate-Citrate Lyase Inhibitor [EPC]",
          "Dietary Cholesterol Absorption Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Adenosine Triphosphate-Citrate Lyase Inhibitors [MoA]"
        ],
        "pharm_class_pe": [
          "Decreased Cholesterol Absorption [PE]"
        ],
        "unii": [
          "1EJ6Z6Q368",
          "EOR26LQQ24"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94365",
      "recalling_firm": "Esperion",
      "address_1": "3891 Ranchero Dr Ste 150",
      "address_2": "",
      "postal_code": "48108-2837",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0441-2024",
      "product_description": "NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion Therapeutics, Ann Arbor, MI 48108, NDC 72426-818-03",
      "product_quantity": "3,480 30-count bottles",
      "reason_for_recall": "Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.",
      "recall_initiation_date": "20240327",
      "center_classification_date": "20240412",
      "report_date": "20240424",
      "code_info": "Lot #,  1990305, Exp 08-31-2025",
      "more_code_info": ""
    }
  ]
}