{
  "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": "Ongoing",
      "city": "Wilmington",
      "state": "DE",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA214070"
        ],
        "brand_name": [
          "AIRSUPRA"
        ],
        "generic_name": [
          "ALBUTEROL SULFATE AND BUDESONIDE"
        ],
        "manufacturer_name": [
          "AstraZeneca Pharmaceuticals LP"
        ],
        "product_ndc": [
          "0310-9080"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "RESPIRATORY (INHALATION)"
        ],
        "substance_name": [
          "ALBUTEROL SULFATE",
          "BUDESONIDE"
        ],
        "rxcui": [
          "2665906",
          "2665912",
          "2678391",
          "2678392"
        ],
        "spl_id": [
          "8738de51-e5d3-4ac5-910d-a155169ab78e"
        ],
        "spl_set_id": [
          "e60aa9f9-5139-44df-b886-ebddc3c7eb13"
        ],
        "package_ndc": [
          "0310-9080-12",
          "0310-9080-28"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "021SEF3731",
          "Q3OKS62Q6X"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96857",
      "recalling_firm": "AsttraZeneca Pharmaceuticals LP",
      "address_1": "1800 Concord Pike",
      "address_2": "N/A",
      "postal_code": "19897-0001",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0444-2025",
      "product_description": "Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation canister (NDC 0310-9080-12) b) 28-inhalation canister (NDC 0310-9080-28), Rx only, Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, By: AstraZeneca Dunkerque Production (AZDP), Dunkerque, France, Product of France, .",
      "product_quantity": "a) 807,837 canisters; b)  235,698 canisters",
      "reason_for_recall": "Defective delivery system",
      "recall_initiation_date": "20250514",
      "center_classification_date": "20250521",
      "report_date": "20250528",
      "code_info": "Lot#:  a) 6270044C00, 6270040D00, 6270034E00, Exp Date 10/2026; 6270053C00, 6270045C00, 6270047C00, 6270056C00, 6270052C00, 6270063E00 Exp 11/30/2026; 6270064C00, 6270071D00, 6270075D00, 6270075F00 Exp Date 12/31/2026; 6270107C00, Exp Date 9/30/2027; b) Lot 6270019E00, Exp Date 7/31/2025; 6270021D00, Exp 8/31/2025; 6270095C00, Exp 2/28/2026"
    }
  ]
}