Z-0272-2014 Class II Terminated

Recalled by GlaxoSmithKline, LLC. — Zebulon, NC

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.