Reported Aug 19, 2015 · Terminated

SENSODYNE WITH FLUORIDE REPAIR & PROTECT, a) 0.8 oz.(23 g) tubes, (NDC 0135-0548-01); b) 3.4 oz. (96.4 g) tubes, (NDC…

GlaxoSmithkline Consmer Healthcare

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GlaxoSmithkline Consmer Healthcare · 1000 GSK Drive · Moon Township, PA · 15108

4 of 4 products

Products covered by this recall
#	Product as published
1	0.8 oz.(23
2	tubes, (NDC 0135-0548-01)
3	3.4 oz. (96.4
4	tubes, (NDC 0135-0548-02) Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108

Lot codes and dates: Lot # a) R3J181
Exp 08/15 R4A191
R4A192
R41291
R4B011
Exp 12/15 R4C111
Exp 02/16 Lot # b) R3G291
R3H011
Exp 06/15 R3H191
R3H261
R3H291
Exp 07/15 R3J171
R3J182
R3J191
R3J241
Exp 08/15 R3K031
R3K121
R3K221
R3K291
Exp 09/15 R3M111
R3M181
Exp 10/15 R3N081
R3N101
Exp 11/15 R4A211
Exp 12/15 R4B281
Exp 01/16 R4C041
R4C291
R4D021
Exp 02/16 R4D081
Exp 03/16 R4E231
Exp 04/16 R4F081
Exp 05/16 R4G191
Exp 06/16 R4H031
R4H071
R4H271
Exp 07/16
Amount recalled: 325,504 tubes

The agency filed one notice per product. You are reading one of them; the other 7 are below.

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

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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