GlaxoSmithkline Consmer Healthcare recalls biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by Glax…

Recall date

July 15, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1317-2015

FDA classification

Class II

Brand / firm

GlaxoSmithkline Consmer Healthcare

Sold / distributed

Nationwide, Puerto Rico & Taiwan

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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