FDAFDA · Food and drugs·Recall number D-1319-2015
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
Published August 19, 2015 · Recall initiated: July 15, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BIOTENE
- Manufacturer
- GlaxoSmithkline Consmer Healthcare
- Distributor
- Nationwide, Puerto Rico & Taiwan
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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