{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Durham",
      "state": "NC",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA203975"
        ],
        "brand_name": [
          "ANORO ELLIPTA"
        ],
        "generic_name": [
          "UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE"
        ],
        "manufacturer_name": [
          "GlaxoSmithKline LLC"
        ],
        "product_ndc": [
          "0173-0869"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "RESPIRATORY (INHALATION)"
        ],
        "substance_name": [
          "UMECLIDINIUM BROMIDE",
          "VILANTEROL TRIFENATATE"
        ],
        "rxcui": [
          "1487519",
          "1487524",
          "1487527",
          "1487528"
        ],
        "spl_id": [
          "90be6e26-9d2d-4b9d-8378-5e38c3076720"
        ],
        "spl_set_id": [
          "2dbd0671-c565-40c5-bf0f-e324db26799c"
        ],
        "package_ndc": [
          "0173-0869-10",
          "0173-0869-06",
          "0173-0869-61"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "7AN603V4JV",
          "40AHO2C6DG"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93565",
      "recalling_firm": "GlaxoSmithKline LLC",
      "address_1": "410 Blackwell St",
      "address_2": "",
      "postal_code": "27701-3986",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed Nationwide in the USA and Puerto Rico.",
      "recall_number": "D-0160-2024",
      "product_description": "ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg.  1 inhaler contains 30 doses (60 blisters total), Rx Only, Manufactured by GlaxoSmithKline Durham, NC 27701. NDC 0173-0869-10",
      "product_quantity": "67,508 inhalers",
      "reason_for_recall": "Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification",
      "recall_initiation_date": "20231212",
      "center_classification_date": "20231222",
      "termination_date": "20240912",
      "report_date": "20240103",
      "code_info": "Lot #:  7Y9S. Exp June 2025",
      "more_code_info": ""
    }
  ]
}