{
  "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": "2026-07-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Thousand Oaks",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA206143"
        ],
        "brand_name": [
          "CORLANOR"
        ],
        "generic_name": [
          "IVABRADINE"
        ],
        "manufacturer_name": [
          "Amgen Inc"
        ],
        "product_ndc": [
          "55513-800",
          "55513-810",
          "55513-813"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "IVABRADINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1649485",
          "1649491",
          "1649493",
          "1649495",
          "2168592",
          "2168596"
        ],
        "spl_id": [
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        "spl_set_id": [
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        ],
        "package_ndc": [
          "55513-800-60",
          "55513-800-99",
          "55513-810-60",
          "55513-813-01",
          "55513-813-28"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0355513800600",
          "0355513810609"
        ],
        "unii": [
          "TP19837BZK"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99077",
      "recalling_firm": "Amgen, Inc.",
      "address_1": "1 Amgen Center Dr",
      "address_2": "N/A",
      "postal_code": "91320-1730",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0615-2026",
      "product_description": "Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60",
      "product_quantity": "N/A",
      "reason_for_recall": "Presence of Foreign Substance.",
      "recall_initiation_date": "20260604",
      "center_classification_date": "20260623",
      "report_date": "20260701",
      "code_info": "Lot #: 1138203, 1142065, Exp. Date 07/31/2026; 1145151, 1145152, 1145153, Exp. Date 2/28/2027; 1148908, 1148909, Exp. Date 05/31/2027; 1162845, 1162846, Exp. Date 11/30/2027; 1166471, 1166472, 1166473, Exp. Date 05/31/2028; 1170615, Exp. Date 08/31/2028"
    }
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}