{
  "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 II",
      "openfda": {
        "application_number": [
          "NDA020554"
        ],
        "brand_name": [
          "CALCIPOTRIENE"
        ],
        "generic_name": [
          "CALCIPOTRIENE"
        ],
        "manufacturer_name": [
          "Prasco Laboratories"
        ],
        "product_ndc": [
          "66993-877"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CALCIPOTRIENE"
        ],
        "rxcui": [
          "313921"
        ],
        "spl_id": [
          "3682f2c5-9bce-4b4a-a4d6-9af29f08ad63"
        ],
        "spl_set_id": [
          "377eafda-737c-4ba2-9ec5-61209b8814ed"
        ],
        "package_ndc": [
          "66993-877-61",
          "66993-877-78"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "M0022797",
          "N0000175849"
        ],
        "pharm_class_cs": [
          "Vitamin D [CS]"
        ],
        "pharm_class_epc": [
          "Vitamin D Analog [EPC]"
        ],
        "unii": [
          "143NQ3779B"
        ]
      },
      "product_type": "Drugs",
      "event_id": "76467",
      "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": "Letter",
      "distribution_pattern": "U.S. Nationwide",
      "recall_number": "D-0510-2017",
      "product_description": "Calcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) 120g tube (NDC 66993-877-78), Rx Only,  Manufactured by: LEO Pharma Inc., Dublin, Ireland, Manufactured for: Prasco Laboratories, Mason, OH, 45040",
      "product_quantity": "272,062 tubes",
      "reason_for_recall": "Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.",
      "recall_initiation_date": "20170119",
      "center_classification_date": "20170303",
      "termination_date": "20180124",
      "report_date": "20170315",
      "code_info": "Lot #: a) EK8760, Exp 2/17; EL1115, Exp 3/17; EL2358, Exp 4/17;  EL6143, Exp 7/17; EM0837, Exp 10/17; EM2088, 12/17; A20899, Exp 5/18; A24492, Exp 6/18; b) EK8764, Exp 2/17; EL6145, Exp 7/17; EM2091, Exp 2/17; A25206, Exp 6/18."
    }
  ]
}