Device product
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
Z-0272-2014
Product summary
- Event
- Event 66689
- Status
- Terminated
- Classification
- Class II
- Quantity
- 483,204 bottles
- Official record key
device-enforcement:Z-0272-2014
Official wording
Reason: Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol.
Code information: UPC: 048582001558, Lot numbers U3E031, U3E151, U3E211, U3F201, U3G031, U3G171, U3G231 and U3G311.
Distribution pattern: Nationwide Distribution .
Derived failure modes
-
Unknown
Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol.