{
  "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": "Ongoing",
      "city": "Zebulon",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA020983"
        ],
        "brand_name": [
          "VENTOLIN"
        ],
        "generic_name": [
          "ALBUTEROL SULFATE"
        ],
        "manufacturer_name": [
          "GlaxoSmithKline LLC"
        ],
        "product_ndc": [
          "0173-0682"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "RESPIRATORY (INHALATION)"
        ],
        "substance_name": [
          "ALBUTEROL SULFATE"
        ],
        "rxcui": [
          "801092",
          "801095",
          "859088",
          "2123076"
        ],
        "spl_id": [
          "cce067df-7227-44ec-9bad-494bce12db01"
        ],
        "spl_set_id": [
          "d92c5d6b-ff10-4087-36a2-1cfc464cb967"
        ],
        "package_ndc": [
          "0173-0682-20",
          "0173-0682-24"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "021SEF3731"
        ]
      },
      "product_type": "Drugs",
      "event_id": "77329",
      "recalling_firm": "GlaxoSmithKline, LLC",
      "address_1": "1011 N Arendell Ave",
      "address_2": "",
      "postal_code": "27597-2309",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the US and  Puerto Rico",
      "recall_number": "D-0793-2017",
      "product_description": "Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20.",
      "product_quantity": "562,883",
      "reason_for_recall": "Defective Delivery System: Elevated number of units with out of specification results for leak rate",
      "recall_initiation_date": "20170516",
      "center_classification_date": "20170522",
      "report_date": "20170531",
      "code_info": "Lot#: 7ZP0634, 7ZP0810, 7ZP0990, Exp. 5/18",
      "more_code_info": ""
    }
  ]
}