Drug product
SENSODYNE EXTRA FRESH 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 0135-0572-02
D-1321-2015
Product summary
- Event
- Event 71750
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50,860 tubes
- Official record key
drug-enforcement:D-1321-2015
Official wording
Reason: Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Code information: Lot # C4D061, Exp 03/16 C4E161, C4E211, Exp 04/16 C4F051, Exp 05/16 C4H111, Exp 07/16
Distribution pattern: Nationwide, Puerto Rico & Taiwan
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance