{
  "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": "Westborough",
      "state": "MA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA020929"
        ],
        "brand_name": [
          "PULMICORT RESPULES"
        ],
        "generic_name": [
          "BUDESONIDE"
        ],
        "manufacturer_name": [
          "AstraZeneca Pharmaceuticals LP"
        ],
        "product_ndc": [
          "0186-1988",
          "0186-1989",
          "0186-1990"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "RESPIRATORY (INHALATION)"
        ],
        "substance_name": [
          "BUDESONIDE"
        ],
        "rxcui": [
          "252559",
          "349094",
          "351109",
          "616817",
          "616819",
          "616830"
        ],
        "spl_id": [
          "76a8044c-b6f4-4da4-b855-a281fdca66b4"
        ],
        "spl_set_id": [
          "33cd9834-76df-4f26-3fa2-aab6b9eee8f2"
        ],
        "package_ndc": [
          "0186-1988-04",
          "0186-1989-04",
          "0186-1990-04"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "Q3OKS62Q6X"
        ]
      },
      "product_type": "Drugs",
      "event_id": "64041",
      "recalling_firm": "AstraZeneca LP",
      "address_1": "50 Otis Street",
      "address_2": "N/A",
      "postal_code": "01581-4500",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-198-2013",
      "product_description": "PULMICORT RESPULES 0.25 mg/2 ml   Budesonide Inhalation Suspension  (30 ampules/carton)  NDC: 0186-1988-04",
      "product_quantity": "28,476 cartons",
      "reason_for_recall": "Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.",
      "recall_initiation_date": "20130111",
      "center_classification_date": "20130312",
      "termination_date": "20130726",
      "report_date": "20130320",
      "code_info": "Lot/Exp date:  AH0054 Exp 5/14; AK0125 Exp 7/14",
      "more_code_info": ""
    }
  ]
}