Events

Recall of Biotene Moisturizing Mouth Spray

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GlaxoSmithKline, LLC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66689
  • Event Risk Class
    Class 2
  • Event Number
    Z-0272-2014
  • Event Initiated Date
    2013-10-17
  • Event Date Posted
    2013-11-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122970
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Saliva, artificial - Product Code LFD
  • Reason
    Label indicates, "sweetened with xylitol and sorbitol", however product does not contain sorbitol.
  • 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. Customers with questions should call Customers Service at 1-800-743-4014. For questions regarding this recall call 919-269-1194.

Device

Biotene Moisturizing Mouth Spray
  • Model / Serial
    UPC: 048582001558, Lot numbers U3E031, U3E151, U3E211, U3F201, U3G031, U3G171, U3G231 and U3G311.
  • Product Classification
    Dental Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution .
  • 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. || Biotene Mouth Spray is used for the treatment of dry mouth
  • Manufacturer
    GlaxoSmithKline, LLC.

Manufacturer

GlaxoSmithKline, LLC.
  • Manufacturer Address
    GlaxoSmithKline, LLC., 1011 North Arendell Ave, Zebulon NC 27597-1217
  • Manufacturer Parent Company (2017)
    Glaxosmithkline Plc
  • Source
    USFDA