{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA021537"
        ],
        "brand_name": [
          "CIPROFLOXACIN AND DEXAMETHASONE"
        ],
        "generic_name": [
          "CIPROFLOXACIN AND DEXAMETHASONE"
        ],
        "manufacturer_name": [
          "Sandoz Inc"
        ],
        "product_ndc": [
          "0781-6186"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "AURICULAR (OTIC)"
        ],
        "substance_name": [
          "CIPROFLOXACIN HYDROCHLORIDE",
          "DEXAMETHASONE"
        ],
        "rxcui": [
          "403908"
        ],
        "spl_id": [
          "39a8b845-aa32-4c9d-bef8-18cea1ef7bc9"
        ],
        "spl_set_id": [
          "89fef4d2-7078-47f1-96bf-aca50b135a97"
        ],
        "package_ndc": [
          "0781-6186-67"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0307816186677"
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "4BA73M5E37",
          "7S5I7G3JQL"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97431",
      "recalling_firm": "Sandoz Inc",
      "address_1": "100 College Rd W",
      "address_2": "N/A",
      "postal_code": "08540-6604",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed to one consignee in CA.",
      "recall_number": "D-0626-2025",
      "product_description": "Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manufacturing NV, Belgium, Distributed by: Sandoz, Inc., Princeton, NJ,  NDC# 0781-6186-67, Carton NDC# 0781-6186-67",
      "product_quantity": "1,680 bottles",
      "reason_for_recall": "Temperature Abuse",
      "recall_initiation_date": "20250813",
      "center_classification_date": "20250910",
      "report_date": "20250917",
      "code_info": "Lot # VNF35A, Exp.08/31/2026"
    }
  ]
}