Drug product
parodontax WHITENING (Stannous fluoride) Daily Fluoride Anticavity and Antigingivitis Toothpaste, 0.454% (0.15% w/v fluoride ion), 3.4 OZ (96.4 g) tube, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059, NDC 0135-0601-01.
D-0944-2017
Product summary
- Event
- Event 77651
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15,708 tubes
- Official record key
drug-enforcement:D-0944-2017
Official wording
Reason: Presence of Foreign Substance: possibility of the presence of metal in the product.
Code information: G7E101, Exp 04/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance