Drug product
SENSODYNE COMPLETE PROTECTION, 3.4 oz. (96.4 g)tubes, Manufactured by Oratech, South Jordan UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0573-02
D-1322-2015
Product summary
- Event
- Event 71750
- Status
- Terminated
- Classification
- Class II
- Quantity
- 81,376 tubes
- Official record key
drug-enforcement:D-1322-2015
Official wording
Reason: Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Code information: Lot # B4D031, Exp 03/16 B4E101, Exp 04/16 B4F261,B4F291,B4G011, Exp 05/16 B4G031, B4G091, Exp 06/16 B4J031, Exp 07/16
Distribution pattern: Nationwide, Puerto Rico & Taiwan
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance