Drug product
biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0488-01
D-1317-2015
Product summary
- Event
- Event 71750
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30,516 tubes
- Official record key
drug-enforcement:D-1317-2015
Official wording
Reason: Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Code information: Lot # Y2J101, Y2J111, Exp 08/15 Y3D031, Exp 02/16
Distribution pattern: Nationwide, Puerto Rico & Taiwan
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance