{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Columbus",
      "state": "OH",
      "country": "United States",
      "classification": "Class III",
      "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": "67796",
      "recalling_firm": "Boehringer Ingelheim Roxane Inc",
      "address_1": "1809 Wilson Rd",
      "address_2": "N/A",
      "postal_code": "43228-9579",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-1230-2014",
      "product_description": "Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Only, 18 mcg (as tiotropium) per capsule, Rx Only, a) NDC 0597-0075-75, 5 Spiriva capsules per blister card, b) NDC 0597-0075-41, 30 Spiriva capsules per blister card, Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany, Marketed by: Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT 06877 USA and Pfizer Inc New York, NY 10017 USA, Made in Germany.",
      "product_quantity": "1,276,710 Blister Cards",
      "reason_for_recall": "Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.",
      "recall_initiation_date": "20140327",
      "center_classification_date": "20140410",
      "termination_date": "20150126",
      "report_date": "20140416",
      "code_info": "a) 5 count capsule blister card: 303012A, Exp Sep 2014;  b) 30 count capsules blister card: 303012B, Exp Sep 2014, 303125A, 303253A, Exp Oct 2014, 303895A, 304282A, Exp Nov 2014, 304510A, Exp Dec 2014"
    }
  ]
}