{
  "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",
          "0597-0075-27"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "L64SXO195N"
        ]
      },
      "product_type": "Drugs",
      "event_id": "65428",
      "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",
      "recall_number": "D-1057-2013",
      "product_description": "SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 count blister (NDC 0597-0075-27), b) 30 count blister (NDC 0597-0075-41), c) 90 count blister (NDC 0597-0075-47), d) 5 count blister physician sample (NDC 0597-0075-75), Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany",
      "product_quantity": "15,385,232 capsules",
      "reason_for_recall": "Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA Handihaler",
      "recall_initiation_date": "20130830",
      "center_classification_date": "20130916",
      "termination_date": "20140616",
      "report_date": "20130925",
      "code_info": "Lot Number/Exp. Date:   202477A/Sep-13, 202480A/Sep-13, 202556B/Sep-13, 202603A/Sep-13, 202784B/Sep-13, 202844A/Sep-13, 202951A/Sep-13, 203041A/Sep-13,  203042A,Sep-13, 203280A/Oct-13, 203281A/Oct-13, 203364A/Oct-13,  203440A,Oct-13, 203569B/Oct-13, 203588A/Oct-13, 203890B/Nov-13,  204094A/Nov-13, 203660A/Nov-13, 203690A/Nov-13, 203890A/Nov-13,  203980A/Nov-13, 203981B/Nov-13, 204356B/Dec-13, 204357A/Dec-13,  204821A/Dec-13, 204459A/Dec-13, 204552C/Dec-13, 204822A/Dec-13,  204944A/Jan-14, 204947A/Jan-14, 205015A/Jan-14, 205163A/Jan-14,   205364A/Jan-14, 205509A/Feb-14, 205737A/Feb-14, 205571A/Feb-14,  205572A/Feb-14, 205674A/Feb-14, 205682A/Feb-14, 205959A/Feb-14,  205987A/Feb-14, 206186B/Mar-14, 206311A/Mar-14, 206606A/Mar-14,  206944B/Apr-14, 207066A/Apr-14, 206609A/Apr-14, 206729A/Apr-14,  206899A/Apr-14, 206900A/ Apr-14, 207065B/Apr-14, 207191A/May-14,  207199A/May-14, 207352A/May-14, 207420A/May-14, 207577B/May-14,  207691A/May-14, 207692A/May-14, 207778A/May-14, 207818A/Jun-14,  301378A/Jul-14, 301476B/Jul-14, 301699B/Jul-14, 301867A/Aug-14,  202530/Sep-13, 203195A/Oct-13, 203366C/Nov-13, 204067A/Nov-13,  204460B/Dec-13, 204551A/Dec-13, 205260A/Jan-14, 206064B/Mar-14,  206185A/Mar-14, 206939A/Apr-14, 207038A/May-14, 301699A/Jul-14,  202556A/Sep-13, 203569A/Oct-13, 203981A/Nov-13, 204674A/Dec-13,  205737B/Feb-14, 206944A/Apr-14, 207577A/May-14, 301476A/Jul-14  Physician Drug Samples:   203076A/Oct-13, 203891A/Nov-13, 204674B/Dec-13, 205867A/Feb-14,  206731A/Apr-14",
      "more_code_info": ""
    }
  ]
}