FDA-Drug2015-08-19Class II

biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0488-01

GlaxoSmithkline Consmer Healthcare
Hazard

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

Sold states
Nationwide, Puerto Rico & Taiwan
Affected count
30,516 tubes
Manufactured in
1000 GSK Drive, N/A, Moon Township, PA, United States
Products
biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0488-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1317-2015

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