Recall Z-0272-2014
GlaxoSmithKline, LLC. · initiated October 17, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: UPC: 048582001558, Lot numbers U3E031, U3E151, U3E211, U3F201, U3G031, U3G171, U3G231 and U3G311.
Reason for recall
Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol.
FDA-determined cause: Labeling Change Control
Action taken
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.
Details
- Recall number
- Z-0272-2014
- Initiated
- October 17, 2013
- Posted by FDA
- November 13, 2013
- Terminated
- July 26, 2017
- Product code
- LFD – Saliva, Artificial
- Quantity
- 483,204 bottles
- Distribution
- Nationwide Distribution .
- Recalling firm
- GlaxoSmithKline, LLC., Zebulon, NC