{
  "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": "2026-03-18",
    "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": "76767",
      "recalling_firm": "G & W  Laboratories, Inc.",
      "address_1": "111 Coolidge St",
      "address_2": "N/A",
      "postal_code": "07080-3895",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide in the USA and Puerto Rico",
      "recall_number": "D-0636-2017",
      "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 Plainfeld, NJ 07080.",
      "product_quantity": "230,700 tubes",
      "reason_for_recall": "Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.",
      "recall_initiation_date": "20170320",
      "center_classification_date": "20170404",
      "termination_date": "20180214",
      "report_date": "20170412",
      "code_info": "Lot #: a) 63800090, Exp 04/17; 63800095, Exp 11/17; 1000573, Exp 02/18; 1002560, Exp 06/18; b) 63800090, Exp 04/17; 63800092, Exp 07/17; 63800093, Exp 08/17; 63800095, Exp 11/17; 1000574, Exp 02/18; 1001772, Exp 05/18; c) 63800089, Exp 03/17; 63800091, Exp 07/17; 63800094, Exp 08/17; 1000842, Exp 01/18; 1000966, Exp 03/18; 1001771, Exp 05/18; 1002562, Exp 06/18."
    }
  ]
}