Recalls / Class II
Class IID-1321-2015
Product
SENSODYNE EXTRA FRESH COMPLETE PROTECTION, 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 0135-0572-02
- Brand name
- Sensodyne Complete Protection
- Generic name
- Stannous Fluoride
- Active ingredient
- Stannous Fluoride
- Route
- Dental
- NDCs
- 0135-0572, 0135-0573
- FDA application
- M022
- Affected lot / code info
- Lot # C4D061, Exp 03/16 C4E161, C4E211, Exp 04/16 C4F051, Exp 05/16 C4H111, Exp 07/16
Why it was recalled
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Recalling firm
- Firm
- GlaxoSmithkline Consmer Healthcare
- Manufacturer
- Haleon US Holdings LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1000 GSK Drive, N/A, Moon Township, Pennsylvania 15108
Distribution
- Quantity
- 50,860 tubes
- Distribution pattern
- Nationwide, Puerto Rico & Taiwan
Timeline
- Recall initiated
- 2015-07-15
- FDA classified
- 2015-08-11
- Posted by FDA
- 2015-08-19
- Terminated
- 2017-04-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1321-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.