GlaxoSmithkline Consmer Healthcare recalls SENSODYNE WITH FLUORIDE REPAIR & PROTECT, a) 0.8 oz.(23 g) tubes, (NDC 0135-0548-01); b) 3.4 oz. (96.4 g) tubes, (NDC 0…

Recall date

July 15, 2015

Source

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

Recall number

D-1324-2015

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

SENSODYNE WITH FLUORIDE REPAIR & PROTECT, a) 0.8 oz.(23 g) tubes, (NDC 0135-0548-01); b) 3.4 oz. (96.4 g) tubes, (NDC 0135-0548-02) Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108