FDA Drug recall D-0364-2018

Toothette Oral Care Single Use System With Perox-A-Mint solution

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 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-0364-2018
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. Contains: 2 Toothette Plus swabs with sodium bicarbonate, .25 fl oz/7ml tube of Perox-A-Mint solution. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6012 UPC (01)00618029800077

Reason

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

Identifiers

code_info	Product Code: 6012; Lots: 51502, EXP 08/15/2017; 51883, 09/06/2017; 53585, EXP12/19/2018; 54222, 54226, EXP 02/06/2018;… Product Code: 6012; Lots: 51502, EXP 08/15/2017; 51883, 09/06/2017; 53585, EXP12/19/2018; 54222, 54226, EXP 02/06/2018; 54811, EXP 03/21/2018; 55574, EXP 05/08/2018; 56190, EXP 06/12/2018; 56346, EXP 06/26/2018; 56616, EXP 07/12/2018; 57066, EXP 08/07/2018; 57873, EXP 09/25/2018; 58634, EXP 08/28/2018; 58664, EXP 11/06/2018; 59719, EXP 01/02/2019; 61340, EXP 04/02/2019; 62326, EXP 06/11/2019

code_info

Product Code: 6012; Lots: 51502, EXP 08/15/2017; 51883, 09/06/2017; 53585, EXP12/19/2018; 54222, 54226, EXP 02/06/2018;…

Product Code: 6012; Lots: 51502, EXP 08/15/2017; 51883, 09/06/2017; 53585, EXP12/19/2018; 54222, 54226, EXP 02/06/2018; 54811, EXP 03/21/2018; 55574, EXP 05/08/2018; 56190, EXP 06/12/2018; 56346, EXP 06/26/2018; 56616, EXP 07/12/2018; 57066, EXP 08/07/2018; 57873, EXP 09/25/2018; 58634, EXP 08/28/2018; 58664, EXP 11/06/2018; 59719, EXP 01/02/2019; 61340, EXP 04/02/2019; 62326, EXP 06/11/2019

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-0364-2018%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.