Z-0272-2014 Class II Terminated
FDA device recall Z-0272-2014 was initiated by GlaxoSmithKline, LLC. on Oct 17, 2013 and is designated Class II. Reason for recall: Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol. The recall status is terminated (terminated Jul 26, 2017). Affected quantity: 483,204 bottles.
Recall details
- Product Type
- Devices
- Report Date
- Nov 20, 2013
- Initiation Date
- Oct 17, 2013
- Termination Date
- Jul 26, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 483,204 bottles
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.
Distribution pattern
Nationwide Distribution .
Code information
UPC: 048582001558, Lot numbers U3E031, U3E151, U3E211, U3F201, U3G031, U3G171, U3G231 and U3G311.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0272-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026