Why it was recalled
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Product description
biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 g) tubes, (NDC 0135-0559-01), biotene¿ PBF Paste, b) 4.5 oz.(127.6 g) tubes, (NDC 0135-0490-02), 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) Z3M191, Exp 10/15 Z4C081, Exp 02/16 Z4H171, Exp 07/16 b) Z2K301, Exp 10/15 Z3D181, Exp 04/16
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-1320-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 15, 2015
- FDA report date
- Aug 19, 2015
- Quantity
- 50,860 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GlaxoSmithkline Consmer Healthcare
Original FDA data
Every field from FDA enforcement report D-1320-2015, 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) Z3M191, Exp 10/15 Z4C081, Exp 02/16 Z4H171, Exp 07/16 b) Z2K301, Exp 10/15 Z3D181, Exp 04/16
- Postal code
- 15108
- Report date
- Aug 19, 2015
- Product type
- Drugs
- Recall number
- D-1320-2015
- Classification
- Class II
- Recalling firm
- GlaxoSmithkline Consmer Healthcare
- Product quantity
- 50,860 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 PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 g) tubes, (NDC 0135-0559-01), biotene¿ PBF Paste, b) 4.5 oz.(127.6 g) tubes, (NDC 0135-0490-02), 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