{
  "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": "Melville",
      "state": "NY",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA085692"
        ],
        "brand_name": [
          "TRIAMCINOLONE ACETONIDE"
        ],
        "generic_name": [
          "TRIAMCINOLONE ACETONIDE"
        ],
        "manufacturer_name": [
          "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC"
        ],
        "product_ndc": [
          "0168-0002",
          "0168-0003",
          "0168-0004"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "TRIAMCINOLONE ACETONIDE"
        ],
        "rxcui": [
          "1014314",
          "1085644",
          "1085686"
        ],
        "spl_id": [
          "c8c77210-0a99-47c9-8fe3-0f1531110ffa"
        ],
        "spl_set_id": [
          "92a1ded0-8e1a-4994-9c8a-89e84fc85c94"
        ],
        "package_ndc": [
          "0168-0003-15",
          "0168-0003-80",
          "0168-0004-15",
          "0168-0004-80",
          "0168-0004-16",
          "0168-0002-15"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0301680004150",
          "0301680003153",
          "0301680002156",
          "301680004808"
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "F446C597KA"
        ]
      },
      "product_type": "Drugs",
      "event_id": "67329",
      "recalling_firm": "Fougera Pharmaceuticals  Inc.",
      "address_1": "60 Baylis Rd",
      "address_2": "N/A",
      "postal_code": "11747-3838",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide.",
      "recall_number": "D-1152-2014",
      "product_description": "Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York  11747, NDC 0168-0004-80, UPC 3 0168-0004-80 8.",
      "product_quantity": "493,192 tubes",
      "reason_for_recall": "Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.",
      "recall_initiation_date": "20140129",
      "center_classification_date": "20140307",
      "termination_date": "20151208",
      "report_date": "20140319",
      "code_info": "Lot #: 485P, 486P, 487P, 488P, Exp 06/15; 638P, 639P, 640P, Exp 07/15; 753P, 754P, 755P, Exp 08/15; 898P, 756P, 757P, 758P, 899P, 900P, 901P, 902P, Exp 09/15"
    }
  ]
}