{
  "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": "Zebulon",
      "state": "NC",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA021254"
        ],
        "brand_name": [
          "ADVAIR HFA"
        ],
        "generic_name": [
          "FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE"
        ],
        "manufacturer_name": [
          "GlaxoSmithKline LLC"
        ],
        "product_ndc": [
          "0173-0715",
          "0173-0716",
          "0173-0717"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "RESPIRATORY (INHALATION)"
        ],
        "substance_name": [
          "FLUTICASONE PROPIONATE",
          "SALMETEROL XINAFOATE"
        ],
        "rxcui": [
          "896231",
          "896235",
          "896236",
          "896237",
          "896239",
          "896243",
          "896244",
          "896245",
          "896267",
          "896271",
          "896272",
          "896273"
        ],
        "spl_id": [
          "5107b97c-28b3-42a4-8da2-54b5dc05778e"
        ],
        "spl_set_id": [
          "dfaca6f9-3277-47b2-319d-1377917cb54c"
        ],
        "package_ndc": [
          "0173-0715-20",
          "0173-0715-22",
          "0173-0716-20",
          "0173-0716-22",
          "0173-0717-20",
          "0173-0717-22"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "O2GMZ0LF5W",
          "6EW8Q962A5"
        ]
      },
      "product_type": "Drugs",
      "event_id": "63707",
      "recalling_firm": "GlaxoSmithKline, LLC.",
      "address_1": "1011 North Arendell Ave",
      "address_2": "N/A",
      "postal_code": "27597-1217",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico.",
      "recall_number": "D-065-2013",
      "product_description": "Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg  60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709.",
      "product_quantity": "18,676 Aerosol Units",
      "reason_for_recall": "Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.",
      "recall_initiation_date": "20121024",
      "center_classification_date": "20121123",
      "termination_date": "20140911",
      "report_date": "20121205",
      "code_info": "1ZP3065, Exp. Oct-12, 1ZP5453, Exp. Dec-12, 1ZP3315, Exp. May-13, 2ZP9974, Exp. Sep-13."
    }
  ]
}