Z-0272-2014 Class II Terminated
FDA device recall Z-0272-2014 was initiated by GlaxoSmithKline, LLC. on October 17, 2013 and is designated Class II. Reason for recall: Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol. The recall status is terminated (terminated July 26, 2017). Affected quantity: 483,204 bottles.
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2013
- Initiation Date
- October 17, 2013
- Termination Date
- July 26, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 483,204 bottles
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
Reason for Recall
Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol.
Distribution Pattern
Nationwide Distribution .
Code Information
UPC: 048582001558, Lot numbers U3E031, U3E151, U3E211, U3F201, U3G031, U3G171, U3G231 and U3G311.