D-1321-2015 Class II Terminated
FDA drug recall D-1321-2015 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: 50,860 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
- 50,860 tubes
Product Description
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
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 # C4D061, Exp 03/16 C4E161, C4E211, Exp 04/16 C4F051, Exp 05/16 C4H111, Exp 07/16