FDA Recall Terminated

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

Recall: Z-0272-2014 · Initiated October 17, 2013

Recall

Recall Number: Z-0272-2014
Event Number: 66689
Firm: GlaxoSmithKline, LLC.
FEI Number: 1033964
Product Code: LFD
Status: Terminated
Root Cause: Labeling Change Control
Initiated: October 17, 2013
Posted: November 13, 2013
Terminated: July 26, 2017
Address: 1011 North Arendell Ave, Zebulon, NC, 27597-1217

Description

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.

Distribution

Nationwide Distribution .

Quantity

483,204 bottles