Drug 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
D-1319-2015
Product summary
- Event
- Event 71750
- Status
- Terminated
- Classification
- Class II
- Quantity
- 111,892 tubes
- Official record key
drug-enforcement:D-1319-2015
Official wording
Reason: Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Code information: 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
Distribution pattern: Nationwide, Puerto Rico & Taiwan
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance