{
  "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": "Hawthorne",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA090368"
        ],
        "brand_name": [
          "FLUOROURACIL"
        ],
        "generic_name": [
          "FLUOROURACIL"
        ],
        "manufacturer_name": [
          "Taro Pharmaceuticals U.S.A., Inc."
        ],
        "product_ndc": [
          "51672-4118"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "FLUOROURACIL"
        ],
        "rxcui": [
          "105583"
        ],
        "spl_id": [
          "170232f3-4992-1e1a-e063-6394a90a38e9"
        ],
        "spl_set_id": [
          "acca0036-f19c-459b-9dfc-9592f1cd588d"
        ],
        "package_ndc": [
          "51672-4118-5",
          "51672-4118-2",
          "51672-4118-6"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000000233",
          "N0000175595"
        ],
        "pharm_class_moa": [
          "Nucleic Acid Synthesis Inhibitors [MoA]"
        ],
        "pharm_class_epc": [
          "Nucleoside Metabolic Inhibitor [EPC]"
        ],
        "unii": [
          "U3P01618RT"
        ]
      },
      "product_type": "Drugs",
      "event_id": "63685",
      "recalling_firm": "Taro Pharmaceuticals U.S.A., Inc.",
      "address_1": "3 Skyline Dr",
      "address_2": "N/A",
      "postal_code": "10532-2174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-086-2013",
      "product_description": "Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical Industries, Ltd. Haifa Bay, Israel 26110, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4118-6.",
      "product_quantity": "39,982 Tubes",
      "reason_for_recall": "Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.",
      "recall_initiation_date": "20121121",
      "center_classification_date": "20121204",
      "termination_date": "20170411",
      "report_date": "20121212",
      "code_info": "Lot #s: 118903, Exp. March 2013; 119477, 119483, 119743, Exp. May 2013; 119748, June 2013; 110440, Exp. September 2013; 110599, 110602, 110606, 110607, 110949, 110951, 110953, 110954, 110956, 110958, Exp. October 2013; 110962, 110963, 110965, 111659, 111844, Exp. November 2013; 111845, 111846, Exp. December 2013; 112227, 112228, Exp. January 2014."
    }
  ]
}