GlaxoSmithkline Consmer Healthcare: 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)

Is my product affected?

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

• Brand BIOTENE

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

What happened

GlaxoSmithKline Consumer Healthcare is recalling Biotene Gentle Formula Fluoride Toothpaste in Fresh Mint Original across multiple package sizes due to the presence of wood fragments found when the product was extruded onto a toothbrush. The recall affects 366,192 tubes distributed nationwide, as well as in Puerto Rico and Taiwan. The affected products include 0.70 oz tubes (NDC 0135-0557-02), 0.75 oz tubes (NDC 0135-0487-02), and various lot numbers with expiration dates ranging from July 2015 through June 2017.

Consumers can identify affected products by checking the lot numbers and expiration dates listed in the recall details. The source document does not specify what remedy is available to affected consumers.

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: 366,192 tubes Lot/code info: 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

Source

Official record: FDA (Drug enforcement) ↗

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

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