FDA-Drug2015-08-19Class II

SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. (96.4 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0547-02

GlaxoSmithkline Consmer Healthcare
Hazard

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

Sold states
Nationwide, Puerto Rico & Taiwan
Affected count
335,676 tubes
Manufactured in
1000 GSK Drive, N/A, Moon Township, PA, United States
Products
SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. (96.4 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0547-02

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1323-2015

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