Why it was recalled
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Product description
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
Lot numbers, UPCs & expiration codes
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
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-1324-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 15, 2015
- FDA report date
- Aug 19, 2015
- Quantity
- 325,504 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GlaxoSmithkline Consmer Healthcare
Original FDA data
Every field from FDA enforcement report D-1324-2015, 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) 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
- Postal code
- 15108
- Report date
- Aug 19, 2015
- Product type
- Drugs
- Recall number
- D-1324-2015
- Classification
- Class II
- Recalling firm
- GlaxoSmithkline Consmer Healthcare
- Product quantity
- 325,504 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 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
- Distribution pattern
- Nationwide, Puerto Rico & Taiwan
- Recall initiation date
- Jul 15, 2015
- Initial firm notification
- Letter
- Center classification date
- Aug 11, 2015