FDA recall D-0944-2017

GSK Consumer Healthcare · Class II · 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.

Reason for recall

Presence of Foreign Substance: possibility of the presence of metal in the product.

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2017-06-28
Report date
2017-07-12
Termination date
2020-02-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warren, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0944-2017