{
  "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": [
          "8ab000cd-0258-489a-b1bb-4cc1ca359d6c"
        ],
        "spl_set_id": [
          "92018a65-38f6-45f7-91d4-a34921b81d0d"
        ],
        "package_ndc": [
          "55513-800-60",
          "55513-800-99",
          "55513-810-60",
          "55513-813-01",
          "55513-813-28"
        ],
        "is_original_packager": [
          true
        ],
        "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-0612-2026",
      "product_description": "Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy.",
      "product_quantity": "934577 bottles",
      "reason_for_recall": "Presence of Foreign Substance.",
      "recall_initiation_date": "20260604",
      "center_classification_date": "20260623",
      "report_date": "20260701",
      "code_info": "a) Lot # 1138901, Exp. Date 08/31/2026; 1149846, Exp. Date 04/30/2027 b) Lot #1138201, 1138202,  08/31/2026, 1138900, 1141143, Exp. Date 08/31/2026; 1140280, 1140281, 1142063, Exp. Date 10/31/2026; 1142062, 1142942, 1142943, Exp. Date 11/30/2026; 1144081, 1144104, Exp. Date 12/31/2026; 1146373, 1146374, Exp. Date 01/31/2027; 1147491, 1147492, 1149843, Exp. Date 03/31/2027; 1151113, 1151890, 1153401, Exp. Date 07/31/2027; 1151114, 1151115, Exp. Date 09/30/2027; 1152412, 1153399, 1153400, Exp. Date 06/30/2027; 1155834, 1155835, Exp. Date 04/30/2027; 1155836, Exp. Date 09/30/2027; 1158480, 1158481, 1158482, Exp. Date 10/31/2027; 1160354, 1160355, Exp. Date 03/31/2028; 1161593, 1161594, 1161595, Exp. Date 04/30/2028; 1164097, 1164098, 1164099, Exp. Date 06/30/2028; 1165078, 1165079, Exp Date 07/31/2028; 1165080, Exp. Date 02/29/2028;1168005, 1168006, 1168007, Exp. Date 09/30/2028; 1169288, 1169289, Exp. Date 10/31/2028; 1172885, Exp. Date 12/31/2028."
    }
  ]
}