{
  "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": [
          "ANDA089526"
        ],
        "brand_name": [
          "FLUOCINOLONE ACETONIDE"
        ],
        "generic_name": [
          "FLUOCINOLONE ACETONIDE"
        ],
        "manufacturer_name": [
          "Cosette Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "0713-0223",
          "0713-0222",
          "0713-0224"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "FLUOCINOLONE ACETONIDE"
        ],
        "rxcui": [
          "1191256",
          "1191302",
          "1191315"
        ],
        "spl_id": [
          "0abbbbe6-b694-1260-e063-6294a90a6f81"
        ],
        "spl_set_id": [
          "de5b78ab-ff79-3e0f-cad4-ecab11ebbdcd"
        ],
        "package_ndc": [
          "0713-0222-15",
          "0713-0222-60",
          "0713-0223-15",
          "0713-0223-60",
          "0713-0224-15",
          "0713-0224-60"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "0CD5FD6S2M"
        ],
        "upc": [
          "022212012022"
        ]
      },
      "product_type": "Drugs",
      "event_id": "66454",
      "recalling_firm": "G & W  Laboratories Inc",
      "address_1": "111 Coolidge St",
      "address_2": "",
      "postal_code": "07080-3895",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-391-2014",
      "product_description": "G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ), Rx Only, Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080",
      "product_quantity": "187,368 metal tubes",
      "reason_for_recall": "Failed Content Uniformity Specifications; at the 18 month time point.",
      "recall_initiation_date": "20130930",
      "center_classification_date": "20131227",
      "termination_date": "20140828",
      "report_date": "20140108",
      "code_info": "15 gm Lot #: 022211002, 022212001- 022212008, 022212010-022212012, 022212017, 022213001, 022213005, 022213008   60 gm Lot #: 022211002, 022212001- 022212007, 022212009, 022212010, 022212012-022212016, 022212018, 022212019,  022213002.",
      "more_code_info": ""
    }
  ]
}