FDA-Drug2017-04-05Class II

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

GSK Consumer Healthcare
Hazard

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

Sold states
Nationwide
Affected count
56,840 cases
Manufactured in
184 Liberty Corner Rd Ste 200, Warren, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0624-2017

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