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D-0624-2017 Class II Terminated

Recalled by GSK Consumer Healthcare — Warren, NJ

Recall Details

Product Type: Drugs
Report Date: April 5, 2017
Initiation Date: March 6, 2017
Termination Date: May 31, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 56,840 cases

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

Distribution Pattern

Nationwide

Code Information

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