{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Completed",
      "city": "Dawsonville",
      "state": "GA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA086413"
        ],
        "brand_name": [
          "TRIAMCINOLONE ACETONIDE"
        ],
        "generic_name": [
          "TRIAMCINOLONE ACETONIDE CREAM"
        ],
        "manufacturer_name": [
          "Direct Rx"
        ],
        "product_ndc": [
          "72189-330"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "TRIAMCINOLONE ACETONIDE"
        ],
        "rxcui": [
          "1014314"
        ],
        "spl_id": [
          "2c3d5768-7eac-50ff-e063-6394a90afae0"
        ],
        "spl_set_id": [
          "d92e9eaf-3a79-76d7-e053-2995a90ae28d"
        ],
        "package_ndc": [
          "72189-330-80"
        ],
        "original_packager_product_ndc": [
          "45802-064"
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "F446C597KA"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90869",
      "recalling_firm": "Direct Rx",
      "address_1": "94 Worldwide Dr",
      "address_2": "",
      "postal_code": "30534-6828",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Physicians and Medical Facilities in GA and ID",
      "recall_number": "D-1535-2022",
      "product_description": "Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo, Allegan, MI 49010, NDC 72189-330-80.",
      "product_quantity": "20 tubes",
      "reason_for_recall": "CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.",
      "recall_initiation_date": "20220912",
      "center_classification_date": "20220915",
      "report_date": "20220921",
      "code_info": "Lot: 12JY2216, Exp. 2/29/24",
      "more_code_info": ""
    }
  ]
}