Why it was recalled
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Product description
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide, Puerto Rico & Taiwan
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1318-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 15, 2015
- FDA report date
- Aug 19, 2015
- Quantity
- 366,192 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GlaxoSmithkline Consmer Healthcare
Original FDA data
Every field from FDA enforcement report D-1318-2015, exactly as published.
Show all FDA fields
- City
- Moon Township
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 71750
- Address
- 1000 GSK Drive
- 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
- Postal code
- 15108
- Report date
- Aug 19, 2015
- Product type
- Drugs
- Recall number
- D-1318-2015
- Classification
- Class II
- Recalling firm
- GlaxoSmithkline Consmer Healthcare
- Product quantity
- 366,192 tubes
- Termination date
- Apr 19, 2017
- Reason for recall
- Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide, Puerto Rico & Taiwan
- Recall initiation date
- Jul 15, 2015
- Initial firm notification
- Letter
- Center classification date
- Aug 11, 2015