{
  "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": "Terminated",
      "city": "Dublin",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA021395"
        ],
        "brand_name": [
          "SPIRIVA"
        ],
        "generic_name": [
          "TIOTROPIUM BROMIDE"
        ],
        "manufacturer_name": [
          "Boehringer Ingelheim Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "0597-0075"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL",
          "RESPIRATORY (INHALATION)"
        ],
        "substance_name": [
          "TIOTROPIUM BROMIDE MONOHYDRATE"
        ],
        "rxcui": [
          "485032",
          "580261"
        ],
        "spl_id": [
          "94768574-0d3e-46f0-9f75-ab3c9f52857d"
        ],
        "spl_set_id": [
          "820839ef-e53d-47e8-a3b9-d911ff92e6a9"
        ],
        "package_ndc": [
          "0597-0075-41",
          "0597-0075-75",
          "0597-0075-47"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "L64SXO195N"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89450",
      "recalling_firm": "CARDINAL HEALTHCARE",
      "address_1": "7200 Cardinal Pl W",
      "address_2": "",
      "postal_code": "43017-1094",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide USA",
      "recall_number": "D-0197-2024",
      "product_description": "SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 capsules, 3 blister cards, each card contains 10 capsules, Rx only, For oral inhalation only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA.  NDC: 0597-0075-41",
      "product_quantity": "5 units",
      "reason_for_recall": "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.",
      "recall_initiation_date": "20220126",
      "center_classification_date": "20231226",
      "termination_date": "20240929",
      "report_date": "20240103",
      "code_info": "Batch 104440",
      "more_code_info": ""
    }
  ]
}