Recall Z-0272-2014 ยท LFD Saliva, Artificial
GlaxoSmithKline, LLC.
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
| Date | Nov 13, 2013 (initiated Oct 17, 2013) |
| Status | Terminated |
| Reason | Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol. |
| Root cause | Labeling Change Control |
| 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 t |
| Quantity | 483,204 bottles |
| Distribution | Nationwide Distribution . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123731 | BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY Glaxosmithkline Consumer Healthcare (Gskch), Jan 4, 2013 |