{
  "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": "Madison",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA022185"
        ],
        "brand_name": [
          "TACLONEX"
        ],
        "generic_name": [
          "CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE"
        ],
        "manufacturer_name": [
          "LEO Pharma Inc."
        ],
        "product_ndc": [
          "50222-501"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BETAMETHASONE DIPROPIONATE",
          "CALCIPOTRIENE HYDRATE"
        ],
        "rxcui": [
          "833461",
          "833463"
        ],
        "spl_id": [
          "5d56e57e-6b91-4916-96d8-6dca1af7487d"
        ],
        "spl_set_id": [
          "757c914f-dd8d-43cc-a973-212d591af4af"
        ],
        "package_ndc": [
          "50222-501-51",
          "50222-501-06",
          "50222-501-66"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "826Y60901U",
          "S7499TYY6G"
        ]
      },
      "product_type": "Drugs",
      "event_id": "76370",
      "recalling_firm": "LEO PHARMA INC",
      "address_1": "7 Giralda Farms",
      "address_2": "N/A",
      "postal_code": "07940-1051",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide within US",
      "recall_number": "D-0477-2017",
      "product_description": "Taclonex (calcipotriene and betamethasone dipropionate)  Topical Suspension, 0.005%/0.064%, packaged in (a) 60 g (NDC 50222-501-06), and  (b)120 g (50222-501-66)  tubes,  Rx Only, Manufactured by: LEO Laboratories Ltd., 285 Cashel Road, Dublin 12 Ireland, Distributed by: LEO Pharma Inc. 1 Sylvan Way, Parsippany, NJ 07054.",
      "product_quantity": "189,610 units",
      "reason_for_recall": "Labeling: Incorrect or missing package insert:  the affected product was packaged with an out-of-date package insert (PI) dated February 2014.",
      "recall_initiation_date": "20170116",
      "center_classification_date": "20170215",
      "termination_date": "20171212",
      "report_date": "20170222",
      "code_info": "Lot #: (a):  EK9025,  Exp. 2/28/2017; EL1057, Exp. 3/31/2017; EL4637, Exp. 6/30/2017;  EM0825B, Exp. 11/30/2017; EM3992, Exp. 1/31/2019; A22902, Exp. 5/31/2019; A31838, Exp. 9/30/2019  Lot #:EK7007A, EK7007AA,  Exp. 1/31/2017; EL2024, EL2979, Exp. 5/31/2017; EL8069, Exp. 10/31/2017; EA20780AA,  Exp. 5/31/2019.",
      "more_code_info": ""
    }
  ]
}