D-1317-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 19, 2015
- Initiation Date
- July 15, 2015
- Termination Date
- April 19, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30,516 tubes
Product Description
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
Reason for Recall
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Distribution Pattern
Nationwide, Puerto Rico & Taiwan
Code Information
Lot # Y2J101, Y2J111, Exp 08/15 Y3D031, Exp 02/16