{
  "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": "Terminated",
      "city": "Minneapolis",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA086413"
        ],
        "brand_name": [
          "TRIAMCINOLONE ACETONIDE"
        ],
        "generic_name": [
          "TRIAMCINOLONE ACETONIDE"
        ],
        "manufacturer_name": [
          "Padagis Israel Pharmaceuticals Ltd"
        ],
        "product_ndc": [
          "45802-063",
          "45802-064",
          "45802-065"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "TRIAMCINOLONE ACETONIDE"
        ],
        "rxcui": [
          "1014314",
          "1085644",
          "1085686"
        ],
        "spl_id": [
          "afc14b16-9466-4a19-b454-c79d48d76fd3"
        ],
        "spl_set_id": [
          "5d2fe6c2-3856-47f6-843f-077b2e1080a0"
        ],
        "package_ndc": [
          "45802-063-35",
          "45802-063-36",
          "45802-063-05",
          "45802-064-35",
          "45802-064-36",
          "45802-064-05",
          "45802-065-35"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "F446C597KA"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90790",
      "recalling_firm": "Padagis US LLC",
      "address_1": "3940 Quebec Ave N",
      "address_2": "",
      "postal_code": "55427-1244",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-1497-2022",
      "product_description": "Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Perrigo, Allegan, MI 49010, NDC 45802-064-36.",
      "product_quantity": "57,816 tubes",
      "reason_for_recall": "CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.",
      "recall_initiation_date": "20220817",
      "center_classification_date": "20220907",
      "termination_date": "20230928",
      "report_date": "20220907",
      "code_info": "Lot 2CT0486 , Exp 02/29/2024",
      "more_code_info": ""
    }
  ]
}