{
  "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": [
          "ANDA074089"
        ],
        "brand_name": [
          "CLOBETASOL PROPIONATE"
        ],
        "generic_name": [
          "CLOBETASOL PROPIONATE"
        ],
        "manufacturer_name": [
          "Cosette Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "0713-0656"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CLOBETASOL PROPIONATE"
        ],
        "rxcui": [
          "861448"
        ],
        "spl_id": [
          "0b383db5-a99b-f222-e063-6294a90adc09"
        ],
        "spl_set_id": [
          "807d6a1a-4eca-9cf4-f514-bb1cd7b10d0f"
        ],
        "package_ndc": [
          "0713-0656-15",
          "0713-0656-31",
          "0713-0656-37",
          "0713-0656-60"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0307130656313"
        ],
        "unii": [
          "779619577M"
        ]
      },
      "product_type": "Drugs",
      "event_id": "77401",
      "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": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0945-2017",
      "product_description": "G & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 0713-0656-15), b) 30 g tube (NDC 0713-0656-31, c) 45 g tube (NDC 0713-0656-37), d) 60 g tube (NDC 0713-0656-60), Rx Only, Manufactured by G & W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080",
      "product_quantity": "145284 tubes",
      "reason_for_recall": "Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.",
      "recall_initiation_date": "20170602",
      "center_classification_date": "20170706",
      "termination_date": "20180509",
      "report_date": "20170712",
      "code_info": "Lot #: a) 1001090, Exp 8/ 17; 1002881, Exp 2/18; b) 1001086, Exp 8/ 17; 1001154, Exp 11/ 17; 1001156, Exp 9/17; 1002882, Exp 2/18, 1004564, Exp 7/18; c) 1001155, Exp 9/17; 1004572, Exp 7/18; d) 1001158, Exp 9/17; 1001159, Exp 10/17; 1002884, Exp 4/18"
    }
  ]
}