GSK Consumer Healthcare recalls Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% (0.15% w/v fluoride ion)), Net Wt. 3.4 oz, Distributed b…

Recall date

March 6, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0624-2017

FDA classification

Class II

Brand / firm

GSK Consumer Healthcare

Sold / distributed

Nationwide

Why it was recalled

Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% (0.15% w/v fluoride ion)), Net Wt. 3.4 oz, Distributed by Glaxo SmithKline Consumer Healthcare LP Moon Township PA 15108 --- NDC 0135-0575-01, UPC UPC: 3 10158 84060 2