Exact FDA event identifier

Event 66689

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: October 17, 2013
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: GlaxoSmithKline, LLC.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0272-2014

Recall number: Z-0272-2014
Initiated: October 17, 2013
Classification: Class II
Status: Terminated
Recalling firm: GlaxoSmithKline, LLC.
Quantity: 483,204 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

UPC: 048582001558, Lot numbers U3E031, U3E151, U3E211, U3F201, U3G031, U3G171, U3G231 and U3G311.

Distribution pattern

Nationwide Distribution .