{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Ridgefield",
      "state": "CT",
      "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": "78775",
      "recalling_firm": "Boehringer Ingelheim Pharmaceuticals, Inc.",
      "address_1": "900 Ridgebury Rd",
      "address_2": "",
      "postal_code": "06877-1058",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed nationwide",
      "recall_number": "D-0242-2018",
      "product_description": "SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule  (90 capsules (unit dose blisters) per box, Rx Only, Made in Germany, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0075-47",
      "product_quantity": "45,008 units/90 capsules each unit",
      "reason_for_recall": "Failed Stability Specifications",
      "recall_initiation_date": "20171214",
      "center_classification_date": "20180126",
      "termination_date": "20181017",
      "report_date": "20180207",
      "code_info": "Lot # 606478; Exp. 03/18",
      "more_code_info": ""
    }
  ]
}