Drug product
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
D-1320-2015
Product summary
- Event
- Event 71750
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50,860 tubes
- Official record key
drug-enforcement:D-1320-2015
Official wording
Reason: Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Code information: Lot # a) Z3M191, Exp 10/15 Z4C081, Exp 02/16 Z4H171, Exp 07/16 b) Z2K301, Exp 10/15 Z3D181, Exp 04/16
Distribution pattern: Nationwide, Puerto Rico & Taiwan
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance