US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jul 15, 2015 (11 years ago)

biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original, a) 0.70 oz (19.8 g)…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

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

Recalling firm
GlaxoSmithkline Consmer Healthcare
NDC code
0135-0557-02
Origin
PA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1318-2015

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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