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FDA (Drug enforcement)Recalled 2015-07-15closedclass ii

GlaxoSmithkline Consmer Healthcare: 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 J

Is my product affected?

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

  • Brand SENSODYNE

Check against the official notice below — it lists the full affected range.

What happened

GlaxoSmithKline Consumer Healthcare is recalling Sensodyne with Fluoride Repair & Protect toothpaste in two sizes: 0.8 oz. tubes and 3.4 oz. tubes. The recall affects approximately 325,504 tubes that were distributed nationwide, in Puerto Rico, and Taiwan. The product is being recalled because wood fragments were found when the toothpaste was extruded onto a toothbrush.

The affected toothpaste includes multiple lot numbers with expiration dates ranging from June 2015 through July 2016. According to the recall record, no remedy is specified for consumers who have purchased this product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. Distribution: Nationwide, Puerto Rico & Taiwan Quantity: 325,504 tubes Lot/code info: 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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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