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Recall Observatory FDA recall evidence

Drug product

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

D-1317-2015

July 15, 2015

Class II

Product summary

Firm
GlaxoSmithkline Consmer Healthcare
Event
Event 71750
Status
Terminated
Classification
Class II
Quantity
30,516 tubes
Official record key
drug-enforcement:D-1317-2015

Official wording

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

Code information: Lot # Y2J101, Y2J111, Exp 08/15 Y3D031, Exp 02/16

Distribution pattern: Nationwide, Puerto Rico & Taiwan

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Substance