FDAFDA · Food and drugs·Recall number 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
Published August 19, 2015 · Recall initiated: July 15, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GlaxoSmithkline Consmer Healthcare
- Distributor
- Nationwide, Puerto Rico & Taiwan
- Lot
- Lot # a) Z3M191, Exp 10/15 Z4C081, Exp 02/16 Z4H171, Exp 07/16 b) Z2K301, Exp 10/15 Z3D181, Exp 04/16
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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