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U.S. Department of Health and Human Services

Enforcement Report - Week of November 20, 2013

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Product Detail

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
Recall Number Z-0272-2014
Classification Class II
Code Info UPC: 048582001558, Lot numbers U3E031, U3E151, U3E211, U3F201, U3G031, U3G171, U3G231 and U3G311.
Product Distributed Qty 483,204 bottles
Reason For Recall Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol.

Event Detail

Event Id 66689
Product Type Devices
Status Ongoing
Recalling Firm GlaxoSmithKline, LLC.
City Zebulon
State NC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-17
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution .