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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71750

8 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 15, 2015
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GlaxoSmithkline Consmer Healthcare

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

8 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 8

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
Recall number
D-1317-2015
Initiated
July 15, 2015
Classification
Class II
Status
Terminated
Quantity
30,516 tubes

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Foreign Substance

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

drug · product 2 of 8

biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original, a) 0.70 oz (19.8 g) tubes., (NDC 0135-0557-02) , b) 0.75 oz. (21.3 g) tubes, (NDC 0135-0487-02), c) 4.3 oz. (121.9 g) tubes, (NDC 0135-0557-01), d) 4.5 oz. (127.6 g) tubes, (NDC 0135-0487-01), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108

D-1318-2015
Recall number
D-1318-2015
Initiated
July 15, 2015
Classification
Class II
Status
Terminated
Quantity
366,192 tubes

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Foreign Substance

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot # a) X3G121, X3H141, Exp 06/16 X3K121, Exp 09/16 X4D281, Exp 03/17 X4G181, Exp 06/17 b) X3C041, Exp 01/16 c) X3F032, Exp 04/16 X3G101, X3G131, Exp 06/16 X3H171, X3H211, X3H291, Exp 07/16 X3J271, Exp 08/16 X3K021, X3K171, X3K291, Exp 09/16 X3M121, Exp 10/16 X3N171, Exp 11/16 X4B061, X4B081, Exp 01/17 X4C121, X4C251, Exp 02/17 X4D291, X4D301, Exp 03/17 X4E081, X4G131, Exp 04/17 X4H111, Exp 06/17 d) X2H021, Exp 07/15 X2K151, X2K231 Exp 09/15 X3B211,X3C012, X3C011, Exp 01/16 X3C141, X3C251, Exp 02/16 X3G021, Exp 06/16

Distribution pattern

Nationwide, Puerto Rico & Taiwan

drug · product 3 of 8

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
Recall number
D-1319-2015
Initiated
July 15, 2015
Classification
Class II
Status
Terminated
Quantity
111,892 tubes

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Foreign Substance

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

drug · product 4 of 8

biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 g) tubes, (NDC 0135-0559-01), biotene¿ PBF Paste, b) 4.5 oz.(127.6 g) tubes, (NDC 0135-0490-02), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108

D-1320-2015
Recall number
D-1320-2015
Initiated
July 15, 2015
Classification
Class II
Status
Terminated
Quantity
50,860 tubes

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Foreign Substance

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot # a) Z3M191, Exp 10/15 Z4C081, Exp 02/16 Z4H171, Exp 07/16 b) Z2K301, Exp 10/15 Z3D181, Exp 04/16

Distribution pattern

Nationwide, Puerto Rico & Taiwan

drug · product 5 of 8

SENSODYNE EXTRA FRESH COMPLETE PROTECTION, 3.4 oz.(96.4 g) tubes, Manufactured by Oratech, South Jordan UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0572-02

D-1321-2015
Recall number
D-1321-2015
Initiated
July 15, 2015
Classification
Class II
Status
Terminated
Quantity
50,860 tubes

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Foreign Substance

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot # C4D061, Exp 03/16 C4E161, C4E211, Exp 04/16 C4F051, Exp 05/16 C4H111, Exp 07/16

Distribution pattern

Nationwide, Puerto Rico & Taiwan

drug · product 6 of 8

SENSODYNE COMPLETE PROTECTION, 3.4 oz. (96.4 g)tubes, Manufactured by Oratech, South Jordan UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0573-02

D-1322-2015
Recall number
D-1322-2015
Initiated
July 15, 2015
Classification
Class II
Status
Terminated
Quantity
81,376 tubes

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Foreign Substance

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot # B4D031, Exp 03/16 B4E101, Exp 04/16 B4F261,B4F291,B4G011, Exp 05/16 B4G031, B4G091, Exp 06/16 B4J031, Exp 07/16

Distribution pattern

Nationwide, Puerto Rico & Taiwan

drug · product 7 of 8

SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. (96.4 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0547-02

D-1323-2015
Recall number
D-1323-2015
Initiated
July 15, 2015
Classification
Class II
Status
Terminated
Quantity
335,676 tubes

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Foreign Substance

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot # Q3H061, Q3H081, Q3H101, Q3H131, Exp 07/15 Q3J101, Q3J121, Q3J261, Q3J291, Exp 08/15 Q3K161, Q3K181, Q3K211, Q3M021, Exp 09/15 Q3M071, QEM251, Exp 10/15 Q3N021, Q3N211, Exp 11/15 Q4A071, Q4A111, Q4A251, Q4B201, Exp 12/15 Q4C151, Q4C191, Exp 12/16 Q4D111, Q4D151, Q4D151R, Exp 03/16 Q4E151, Q4E151R, Q3E152, Exp 04/16 Q4F161, Q4F201, Exp 05/16 Q4G271, Q4G301, Exp 06/16 Q4J051, Exp 08/16

Distribution pattern

Nationwide, Puerto Rico & Taiwan

drug · product 8 of 8

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 0135-0548-02) Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108

D-1324-2015
Recall number
D-1324-2015
Initiated
July 15, 2015
Classification
Class II
Status
Terminated
Quantity
325,504 tubes

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Foreign Substance

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Nationwide, Puerto Rico & Taiwan