PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 19, 2015 Initiated: July 15, 2015 #D-1324-2015

Product Description

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

Reason for Recall

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

Details

Units Affected
325,504 tubes
Distribution
Nationwide, Puerto Rico & Taiwan
Location
Moon Township, PA

Frequently Asked Questions

What product 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. Recalled by GlaxoSmithkline Consmer Healthcare. Units affected: 325,504 tubes.
Why was this product recalled?
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 19, 2015. Severity: Moderate. Recall number: D-1324-2015.