{
  "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": "2026-06-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA211922"
        ],
        "brand_name": [
          "BUDESONIDE"
        ],
        "generic_name": [
          "BUDESONIDE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "47335-631",
          "47335-632",
          "47335-633"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "RESPIRATORY (INHALATION)"
        ],
        "substance_name": [
          "BUDESONIDE"
        ],
        "rxcui": [
          "252559",
          "349094",
          "351109"
        ],
        "spl_id": [
          "c5265800-f7ea-4258-8555-5465104858a0"
        ],
        "spl_set_id": [
          "a39fbcfc-3ffd-44bd-b882-01f8e1844213"
        ],
        "package_ndc": [
          "47335-631-48",
          "47335-631-49",
          "47335-632-48",
          "47335-632-49",
          "47335-633-48",
          "47335-633-49"
        ],
        "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": "99113",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "N/A",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0607-2026",
      "product_description": "Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Baska Ujeti Road, Ujeti Halol-289350, Gujarat, India, NDC 47335-633-49.",
      "product_quantity": "N/A",
      "reason_for_recall": "Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution",
      "recall_initiation_date": "20260529",
      "center_classification_date": "20260618",
      "report_date": "20260617",
      "code_info": "Lot #: BAG0074A, Exp. Date: 1/31/2027."
    }
  ]
}