Recalls / Class II
Class IID-1319-2015
Product
biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes, Manufactured by Oratech, South Jordan, UTAH, 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 NDC 0135-0558-01
- Brand name
- Biotene
- Generic name
- Sodium Fluoride
- Active ingredient
- Sodium Fluoride
- Route
- Oral
- NDCs
- 0135-0557, 0135-0558
- FDA application
- M022
- Affected lot / code info
- Lot # Y3E211, Exp 04/16 Y3G231, Y3G251, Exp 06/16 Y3J231,Y3N191 Exp 08/16 Y3N171, Exp 11/16 Y4A141, Exp 12/16 Y4C271, Exp 02/17 Y4E131, Exp 04/17 Y4G101, Exp 05/17 Y4H191, Exp 06/17
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
- 111,892 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-1319-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.