FDA Drug · D-1320-2015

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

Class II · Terminated

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

Affected lots / codes — check yours against thisLot # a) Z3M191, Exp 10/15 Z4C081, Exp 02/16 Z4H171, Exp 07/16 b) Z2K301, Exp 10/15 Z3D181, Exp 04/16

Recalling firm: GlaxoSmithkline Consmer Healthcare, Moon Township, PA
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 50,860 tubes
Distribution: Nationwide, Puerto Rico & Taiwan
Recall initiated: July 15, 2015
Classified: August 11, 2015
Terminated: April 19, 2017
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1320-2015%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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