Drug & medication recalls Moderate risk

GlaxoSmithkline Consmer Healthcare recalls biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes, Manufactured by Oratech, South Jordan,…

Recall date
July 15, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-1319-2015
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 Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes, Manufactured by Oratech, South Jordan, UTAH, 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 NDC 0135-0558-01

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