FDA recall D-1324-2015

Product

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.

Distribution

Nationwide, Puerto Rico & Taiwan

Key facts

Status

Terminated

Initiation date

2015-07-15

Report date

2015-08-19

Termination date

2017-04-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Moon Township, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1324-2015