Drug recall D-0624-2017

Class II Terminated reported Apr 5, 2017

Product

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

Lots and codes

A6J231, expiration 08/2018; A6J261, expiration 08/2018; A6K171, expiration 08/2018; A6K241, expiration, 09/2018; A6M231, expiration 10/2018

Recall details

Recalling firm
GSK Consumer Healthcare, Warren, NJ
Quantity
56,840 cases
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
March 6, 2017
Terminated
May 31, 2018

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