March 2017 FDA Recall Sensodyne by Gsk Consumer Healthcare
D-0624-2017 - Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent

This Class II drug recall was voluntarily initiated by Gsk Consumer Healthcare on March 6, 2017 for the product Sensodyne. The FDA reported the reason for recall as presence of foreign substance; low concentration of an additional flavoring ingredient, patchouli oil resulting in complaints of off flavor/scent. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0624-2017

Reason for Recall
Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent
Initiated
03-06-2017
Reported
04-05-2017
Quantity
56,840 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76662
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
GSK Consumer Healthcare
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-31-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

0135-0548-02 Sensodyne Repair And Protect
0135-0548-01 Sensodyne Repair And Protect
0135-0547-02 Sensodyne Repair And Protect Extra Fresh
0135-0575-01 Sensodyne Repair And Protect Whitening