{
  "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": "2026-08-13",
    "results": {
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  "results": [
    {
      "cfres_id": "122970",
      "product_res_number": "Z-0272-2014",
      "event_date_initiated": "2013-10-17",
      "event_date_posted": "2013-11-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-07-26",
      "res_event_number": "66689",
      "product_code": "LFD",
      "k_numbers": [
        "K123731"
      ],
      "product_description": "Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108.\n\nBiotene Mouth Spray is used for the treatment of dry mouth",
      "code_info": "UPC: 048582001558, Lot numbers U3E031, U3E151, U3E211, U3F201, U3G031, U3G171, U3G231 and U3G311.",
      "firm_fei_number": "1033964",
      "recalling_firm": "GlaxoSmithKline, LLC.",
      "address_1": "1011 North Arendell Ave",
      "city": "Zebulon",
      "state": "NC",
      "postal_code": "27597-1217",
      "additional_info_contact": "Randy Pittard\n919-269-1194",
      "reason_for_recall": "Label indicates, \"Sweetened with xylitol and Sorbitol\", however product does not contain sorbitol.",
      "root_cause_description": "Labeling Change Control",
      "action": "GlaxoSmithKline sent an Urgent Medical Device Recall letter dated October 17, 2013, to all affected customers.  The letter identified the product, the problem, and the action to be taken by the customer.  Customers were instructed to return all affected product.  If product was further distributed customers were instructed notify their customers of the recall and the actions required.  Customers were asked to complete and return the enclosed business replay card even if they have no affected product in their inventory.  Customers should complete the return goods packing slip, enclose it with their return goods shipment and affix the return label to the package.  \nCustomers with questions should call Customers Service at 1-800-743-4014.\nFor questions regarding this recall call 919-269-1194.",
      "product_quantity": "483,204 bottles",
      "distribution_pattern": "Nationwide Distribution \n.",
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          "K142549",
          "K851026",
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        "device_name": "Saliva, Artificial",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "U",
        "pma_number": [
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