GlaxoSmithkline Consmer Healthcare recalls biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original, a) 0.70 oz (19.8 g) tubes., (NDC 0135-0557-02) , b) 0.7…

Recall date

July 15, 2015

Source

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

Recall number

D-1318-2015

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 Fresh Mint Original, a) 0.70 oz (19.8 g) tubes., (NDC 0135-0557-02) , b) 0.75 oz. (21.3 g) tubes, (NDC 0135-0487-02), c) 4.3 oz. (121.9 g) tubes, (NDC 0135-0557-01), d) 4.5 oz. (127.6 g) tubes, (NDC 0135-0487-01), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108