{
  "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": "Sanford",
      "state": "FL",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA019452"
        ],
        "brand_name": [
          "DERMOTIC"
        ],
        "generic_name": [
          "FLUOCINOLONE ACETONIDE"
        ],
        "manufacturer_name": [
          "Royal Pharmaceuticals"
        ],
        "product_ndc": [
          "68791-103"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "AURICULAR (OTIC)"
        ],
        "substance_name": [
          "FLUOCINOLONE ACETONIDE"
        ],
        "rxcui": [
          "1191299",
          "1191301"
        ],
        "spl_id": [
          "195c48d9-bb7a-4c89-b6b8-35fff5aefff8"
        ],
        "spl_set_id": [
          "eb00f222-8105-4e05-90e8-bbd129784364"
        ],
        "package_ndc": [
          "68791-103-20"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "0CD5FD6S2M"
        ]
      },
      "product_type": "Drugs",
      "event_id": "67420",
      "recalling_firm": "Hill Dermaceuticals, Inc.",
      "address_1": "2650 S Mellonville Ave",
      "address_2": "N/A",
      "postal_code": "32773-9311",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-1178-2014",
      "product_description": "ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml,  Rx only  Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20",
      "product_quantity": "13,379 bottles",
      "reason_for_recall": "Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.",
      "recall_initiation_date": "20140131",
      "center_classification_date": "20140324",
      "termination_date": "20150203",
      "report_date": "20140402",
      "code_info": "13F015B exp. 12/14, 13G023B exp. 01/15"
    }
  ]
}