{
  "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": "Moon Township",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "BIOTENE"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Haleon US Holdings LLC"
        ],
        "product_ndc": [
          "0135-0557",
          "0135-0558"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "416783",
          "1044547"
        ],
        "spl_id": [
          "95462fd1-5eb4-46ff-bf63-a5e610337bc6"
        ],
        "spl_set_id": [
          "1101c17f-c848-4cd5-a7cd-679b59dbe1bf"
        ],
        "package_ndc": [
          "0135-0557-01",
          "0135-0557-02",
          "0135-0558-01",
          "0135-0487-02",
          "0135-0487-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      },
      "product_type": "Drugs",
      "event_id": "71750",
      "recalling_firm": "GlaxoSmithkline Consmer Healthcare",
      "address_1": "1000 GSK Drive",
      "address_2": "N/A",
      "postal_code": "15108",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide, Puerto Rico & Taiwan",
      "recall_number": "D-1318-2015",
      "product_description": "biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original, a) 0.70 oz (19.8 g) tubes., (NDC 0135-0557-02) , b) 0.75 oz. (21.3 g) tubes, (NDC 0135-0487-02), c) 4.3 oz. (121.9 g) tubes, (NDC 0135-0557-01), d) 4.5 oz. (127.6 g) tubes, (NDC 0135-0487-01), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108",
      "product_quantity": "366,192 tubes",
      "reason_for_recall": "Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.",
      "recall_initiation_date": "20150715",
      "center_classification_date": "20150811",
      "termination_date": "20170419",
      "report_date": "20150819",
      "code_info": "Lot #    a)    X3G121, X3H141, Exp 06/16  X3K121, Exp 09/16  X4D281, Exp 03/17  X4G181, Exp 06/17    b)    X3C041, Exp 01/16    c)    X3F032, Exp 04/16  X3G101, X3G131, Exp 06/16  X3H171, X3H211, X3H291, Exp 07/16  X3J271, Exp 08/16  X3K021, X3K171, X3K291, Exp 09/16  X3M121, Exp 10/16  X3N171, Exp 11/16  X4B061, X4B081, Exp 01/17  X4C121, X4C251, Exp 02/17  X4D291, X4D301, Exp 03/17  X4E081, X4G131, Exp 04/17  X4H111, Exp 06/17    d)    X2H021, Exp 07/15   X2K151, X2K231 Exp 09/15  X3B211,X3C012, X3C011, Exp 01/16  X3C141, X3C251, Exp 02/16  X3G021, Exp 06/16"
    }
  ]
}