D-1317-2015 Class II Terminated
FDA drug recall D-1317-2015 was initiated by GlaxoSmithkline Consmer Healthcare on July 15, 2015 and is designated Class II. Reason for recall: Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. The recall status is terminated (terminated April 19, 2017). Affected quantity: 30,516 tubes.
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