PlainRecalls
FDA Drug Moderate Class II Terminated

biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 g) tubes, (NDC 0135-0559-01), biotene¿ PBF Paste, b) 4.5 oz.(127.6 g) tubes, (NDC 0135-0490-02), 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-1320-2015

Product Description

biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 g) tubes, (NDC 0135-0559-01), biotene¿ PBF Paste, b) 4.5 oz.(127.6 g) tubes, (NDC 0135-0490-02), 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
50,860 tubes
Distribution
Nationwide, Puerto Rico & Taiwan
Location
Moon Township, PA

Frequently Asked Questions

What product was recalled?
biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 g) tubes, (NDC 0135-0559-01), biotene¿ PBF Paste, b) 4.5 oz.(127.6 g) tubes, (NDC 0135-0490-02), 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: 50,860 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-1320-2015.