FDA Drug recall D-0365-2018

Toothette Oral Care Single Use System with Perox-A-Mint solution and Mouth Moisturizer

FDA Drug
Class II
terminated
Published 2018-02-21

On 2018-02-21 the FDA classified a Class II recall of Toothette Oral Care Single Use System with Perox-A-Mint solution and Mouth Moisturizer by Sage Products, citing cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0365-2018
Classification	Class II
Status	terminated
Initiated	2017-08-22
Published	2018-02-21
Last updated	2026-09-13 11:52 UTC
Company	Sage Products
Distribution	US

Product

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

Reason

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

Identifiers

upc	618029800084
code_info	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… 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.

upc

618029800084

code_info

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…

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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0365-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.