{
  "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 II",
      "openfda": {
        "application_number": [
          "NDA021747"
        ],
        "brand_name": [
          "COMBIVENT RESPIMAT"
        ],
        "generic_name": [
          "IPRATROPIUM BROMIDE AND ALBUTEROL"
        ],
        "manufacturer_name": [
          "Boehringer Ingelheim Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "0597-0024"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "RESPIRATORY (INHALATION)"
        ],
        "substance_name": [
          "ALBUTEROL SULFATE",
          "IPRATROPIUM BROMIDE"
        ],
        "rxcui": [
          "1190220",
          "1190225"
        ],
        "spl_id": [
          "aa423748-811c-4bf7-a67f-b38cf394553f"
        ],
        "spl_set_id": [
          "9832312e-0310-4ab6-8501-afa976fc7eb2"
        ],
        "package_ndc": [
          "0597-0024-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "021SEF3731",
          "J697UZ2A9J"
        ]
      },
      "product_type": "Drugs",
      "event_id": "71760",
      "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-1279-2015",
      "product_description": "COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg per actuation*, 4 Grams, 120 Metered Doses per inhaler, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT  06877 USA, Made in Germany, NDC 0597-0024-02.",
      "product_quantity": "358,647 inhalers",
      "reason_for_recall": "Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.",
      "recall_initiation_date": "20150724",
      "center_classification_date": "20150727",
      "termination_date": "20170201",
      "report_date": "20150805",
      "code_info": "Lot #: 408267, Exp 11/17"
    }
  ]
}