PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: April 5, 2017 Initiated: March 6, 2017 #D-0624-2017

Product Description

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

Reason for Recall

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

Details

Recalling Firm
GSK Consumer Healthcare
Units Affected
56,840 cases
Distribution
Nationwide
Location
Warren, NJ

Frequently Asked Questions

What product 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. Recalled by GSK Consumer Healthcare. Units affected: 56,840 cases.
Why was this product recalled?
Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent
Which agency issued this recall?
This recall was issued by the FDA Drug on April 5, 2017. Severity: Moderate. Recall number: D-0624-2017.