FDA recall D-1319-2015

Product

biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes, Manufactured by Oratech, South Jordan, UTAH, 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 NDC 0135-0558-01

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-1319-2015