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FDAFDA · Food and drugs·Recall number D-0365-2018

Toothette Oral Care Single Use System with Perox-A-Mint solution and Mouth Moisturizer. Contains 2 Toothette Plus Swabs with sodium bicarbonate, .25 fl oz/7ml Perox-A-Mint solution and .07 oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6013 UPC 6 18029 80008 4

Published February 21, 2018 · Recall initiated: August 22, 2017

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Sage Products Inc
Distributor
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Lot
Product Code: 6013; Lots: 51361, EXP 8/8/2017; 51834, EXP 9/6/2017; 52473, EXP 10/17/2017; 53225, EXP 11/28/2017; 54102, EXP 1/30/2018; 54754, EXP 3/13/2018; 55222, 55264, EXP 4/10/2018, 56683, EXP 7/17/2018; 57262, EXP 8/21/2018; 57803, EXP 9/18/2018; 58492, EXP 10/30/2018; 59311, EXP 12/4/2018; 60069, EXP 11/27/2018; 61063, EXP 3/19/2019; 61629, EXP 4/17/2019.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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