Drug recall D-1319-2015
Product
biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes, Manufactured by Oratech, South Jordan, UTAH, 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 NDC 0135-0558-01
Reason for recall
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Lots and codes
Lot # Y3E211, Exp 04/16 Y3G231, Y3G251, Exp 06/16 Y3J231,Y3N191 Exp 08/16 Y3N171, Exp 11/16 Y4A141, Exp 12/16 Y4C271, Exp 02/17 Y4E131, Exp 04/17 Y4G101, Exp 05/17 Y4H191, Exp 06/17
Recall details
- Recalling firm
- GlaxoSmithkline Consmer Healthcare, Moon Township, PA
- Quantity
- 111,892 tubes
- Distribution
- Nationwide, Puerto Rico & Taiwan
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 15, 2015
- Terminated
- April 19, 2017
Related products
- Biotene – drug information
- NDC 0135-0558 BIOTENE Gentle Mint · Sodium Fluoride 1.5 mg/g · Haleon US Holdings LLC
- NDC 0135-0557 BIOTENE Fresh Mint Original · Sodium Fluoride 1.5 mg/g · Haleon US Holdings LLC