{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Warren",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA205710"
        ],
        "brand_name": [
          "BUDESONIDE"
        ],
        "generic_name": [
          "BUDESONIDE"
        ],
        "manufacturer_name": [
          "Cipla USA Inc."
        ],
        "product_ndc": [
          "69097-318",
          "69097-319",
          "69097-321"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BUDESONIDE"
        ],
        "rxcui": [
          "252559",
          "349094",
          "351109"
        ],
        "spl_id": [
          "29644146-4bcf-49d0-80b3-e31f4b3a6f54"
        ],
        "spl_set_id": [
          "c52c5382-1400-44b9-95be-a30e1cf706da"
        ],
        "package_ndc": [
          "69097-318-86",
          "69097-318-87",
          "69097-318-32",
          "69097-318-53",
          "69097-319-86",
          "69097-319-87",
          "69097-319-32",
          "69097-319-53",
          "69097-321-86",
          "69097-321-87",
          "69097-321-32",
          "69097-321-53"
        ],
        "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": "90864",
      "recalling_firm": "CIPLA",
      "address_1": "10 Independence Blvd",
      "address_2": "N/A",
      "postal_code": "07059-2730",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA and Puerto Rico",
      "recall_number": "D-1545-2022",
      "product_description": "Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension, Manufactured by: Cipla Ltd., India, Manufactured for Cipla USA Inc., Warren NJ, NDC# 69097-318-86.",
      "product_quantity": "641,160 ampules",
      "reason_for_recall": "Lack of Assurance of Sterility",
      "recall_initiation_date": "20220915",
      "center_classification_date": "20220927",
      "termination_date": "20240110",
      "report_date": "20221005",
      "code_info": "Lot #s: GA20080, GA20081, GA20094, Exp. 01/2024"
    }
  ]
}