Why it was recalled
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Product description
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
Lot numbers, UPCs & expiration codes
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
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-1323-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 15, 2015
- FDA report date
- Aug 19, 2015
- Quantity
- 335,676 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GlaxoSmithkline Consmer Healthcare
Original FDA data
Every field from FDA enforcement report D-1323-2015, 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 # 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
- Postal code
- 15108
- Report date
- Aug 19, 2015
- Product type
- Drugs
- Recall number
- D-1323-2015
- Classification
- Class II
- Recalling firm
- GlaxoSmithkline Consmer Healthcare
- Product quantity
- 335,676 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
- 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
- Distribution pattern
- Nationwide, Puerto Rico & Taiwan
- Recall initiation date
- Jul 15, 2015
- Initial firm notification
- Letter
- Center classification date
- Aug 11, 2015