Recalls / Class II
Class IID-1318-2015
Product
biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original, a) 0.70 oz (19.8 g) tubes., (NDC 0135-0557-02) , b) 0.75 oz. (21.3 g) tubes, (NDC 0135-0487-02), c) 4.3 oz. (121.9 g) tubes, (NDC 0135-0557-01), d) 4.5 oz. (127.6 g) tubes, (NDC 0135-0487-01), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108
- 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 # a) X3G121, X3H141, Exp 06/16 X3K121, Exp 09/16 X4D281, Exp 03/17 X4G181, Exp 06/17 b) X3C041, Exp 01/16 c) X3F032, Exp 04/16 X3G101, X3G131, Exp 06/16 X3H171, X3H211, X3H291, Exp 07/16 X3J271, Exp 08/16 X3K021, X3K171, X3K291, Exp 09/16 X3M121, Exp 10/16 X3N171, Exp 11/16 X4B061, X4B081, Exp 01/17 X4C121, X4C251, Exp 02/17 X4D291, X4D301, Exp 03/17 X4E081, X4G131, Exp 04/17 X4H111, Exp 06/17 d) X2H021, Exp 07/15 X2K151, X2K231 Exp 09/15 X3B211,X3C012, X3C011, Exp 01/16 X3C141, X3C251, Exp 02/16 X3G021, Exp 06/16
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
- 366,192 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-1318-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.