{
  "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": [
          "NDA202331"
        ],
        "brand_name": [
          "EDARBYCLOR"
        ],
        "generic_name": [
          "AZILSARTAN KAMEDOXOMIL AND CHLORTHALIDONE"
        ],
        "manufacturer_name": [
          "Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)"
        ],
        "product_ndc": [
          "60631-412",
          "60631-425"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "AZILSARTAN KAMEDOXOMIL",
          "CHLORTHALIDONE"
        ],
        "rxcui": [
          "1235144",
          "1235150",
          "1235151",
          "1235157"
        ],
        "spl_id": [
          "26b92714-c5ea-943d-e063-6394a90a8341"
        ],
        "spl_set_id": [
          "e60f795b-fce3-4361-aa03-f143451689d1"
        ],
        "package_ndc": [
          "60631-412-30",
          "60631-425-30"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175359",
          "N0000175420"
        ],
        "pharm_class_pe": [
          "Increased Diuresis [PE]"
        ],
        "pharm_class_epc": [
          "Thiazide-like Diuretic [EPC]"
        ],
        "unii": [
          "Q0MQD1073Q"
        ]
      },
      "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-0431-2021",
      "product_description": "edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/25 mg *Each tablet contains: 42.68 mg azilsartan kamedoxomil (equivalent to 40 mg azilsartan medoxomil) and 25 mg chlorthalidone. 30 Tablets Rx Only NDC 60631-425-30 Manufactured for Arbor Pharmaceuticals Atlanta, GA 30328",
      "product_quantity": "273 bottles",
      "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": "79551"
    }
  ]
}