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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

FDA Recall Z-0272-2014 · Posted 2013-11-13

Recalling FirmGlaxoSmithKline, LLC.
Recall StatusTerminated
Product CodeLFD
Date Initiated2013-10-17
Date Terminated2017-07-26
Product Quantity483,204 bottles

Reason for Recall

Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol.

Firm 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.

Root Cause

Labeling Change Control

Distribution Pattern

Nationwide Distribution .

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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