{
  "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": "South Plainfield",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA078463"
        ],
        "brand_name": [
          "CICLOPIROX OLAMINE"
        ],
        "generic_name": [
          "CICLOPIROX OLAMINE"
        ],
        "manufacturer_name": [
          "Cosette Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "0713-0638"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CICLOPIROX OLAMINE"
        ],
        "rxcui": [
          "309289"
        ],
        "spl_id": [
          "ed9669ad-fa01-5788-e053-2995a90a5897"
        ],
        "spl_set_id": [
          "5c585aa5-7d2d-e798-c0bd-d602574d643c"
        ],
        "package_ndc": [
          "0713-0638-15",
          "0713-0638-31",
          "0713-0638-18"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0307130638159"
        ],
        "unii": [
          "50MD4SB4AP"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78974",
      "recalling_firm": "G & W  Laboratories, Inc.",
      "address_1": "200 Helen St",
      "address_2": "N/A",
      "postal_code": "07080-3800",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide in the USA and Puerto Rico",
      "recall_number": "D-0250-2018",
      "product_description": "Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (NDC 0713-0638-31); and c) 90 g tubes (NDC 0713-0638-18), Rx Only, Manufactured by: G&W Laboratories, Inc., South Plainfield, NJ 07080.",
      "product_quantity": "142,236 tubes",
      "reason_for_recall": "Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.",
      "recall_initiation_date": "20180119",
      "center_classification_date": "20180202",
      "termination_date": "20200203",
      "report_date": "20180214",
      "code_info": "Lot #: a) 1002896, Exp 09/18; 1005797, Exp 05/19; 1006100, Exp 07/19; b) 1002561, Exp 06/18; 1002897, Exp 09/18; 1005798, Exp 05/19; 1006101, Exp 07/19; c) 1002898, Exp 10/18; 1004283, Exp 12/18; 1005837, Exp 05/19; 1006321, 1006322, Exp 07/19"
    }
  ]
}