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Recall Observatory FDA recall evidence

Drug 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

D-1319-2015

July 15, 2015

Class II

Product summary

Firm
GlaxoSmithkline Consmer Healthcare
Event
Event 71750
Status
Terminated
Classification
Class II
Quantity
111,892 tubes
Official record key
drug-enforcement:D-1319-2015

Official wording

Reason: Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

Code information: 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

Distribution pattern: Nationwide, Puerto Rico & Taiwan

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Substance