Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened w
FDA device recall Z-0272-2014 · posted 2013-11-13 · Terminated
Recall details
- Recalling firm
- GlaxoSmithKline, LLC.
- Reason for recall
- Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol.
- 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.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- LFD
- Quantity affected
- 483,204 bottles
- Distribution
- Nationwide Distribution .
- Date initiated
- 2013-10-17
- Date posted
- 2013-11-13
- Date terminated
- 2017-07-26
- Location
- Zebulon, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY (K123731) | Glaxosmithkline Consumer Healthcare (Gskch) | 2013-01-04 |