FDA recall D-1318-2015

Product

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

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-1318-2015