{
  "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"
        ],
        "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-1319-2015",
      "product_description": "biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes, Manufactured by Oratech, South Jordan, UTAH, 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 NDC 0135-0558-01",
      "product_quantity": "111,892 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 #    Y3E211, Exp 04/16  Y3G231, Y3G251, Exp 06/16  Y3J231,Y3N191 Exp 08/16  Y3N171, Exp 11/16  Y4A141, Exp 12/16  Y4C271, Exp 02/17  Y4E131, Exp 04/17  Y4G101, Exp 05/17  Y4H191, Exp 06/17"
    }
  ]
}