Recalls / Class II
Class IID-1317-2015
Product
biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0488-01
- Affected lot / code info
- Lot # Y2J101, Y2J111, Exp 08/15 Y3D031, Exp 02/16
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
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1000 GSK Drive, N/A, Moon Township, Pennsylvania 15108
Distribution
- Quantity
- 30,516 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-1317-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.