Recall Z-0272-2014— GlaxoSmithKline, LLC.

Name: FDA recall Z-0272-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-17

Class II · Terminated

Class II FDA medical device recall by GlaxoSmithKline, LLC., initiated 2013-10-17, terminated 2017-07-26. It names one FDA 510(k) clearance: K123731. 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. Reason: Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol..

Recalling firm: GlaxoSmithKline, LLC.
Classification: Class II
Status: Terminated
Initiated: 2013-10-17
Terminated: 2017-07-26
Firm location: Zebulon, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K123731 — BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAYGlaxosmithkline Consumer Healthcare (Gskch)·cleared 2013-01-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.