Recalls / Class II

Class IID-0364-2018

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

Affected lot / 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; 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

Why it was recalled

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

Recalling firm

Firm

Sage Products Inc

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

3909 3 Oaks Rd, Cary, Illinois 60013-1804

Distribution

Quantity

14,753 cases

Distribution pattern

Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand

Timeline

Recall initiated

2017-08-22

FDA classified

2018-02-09

Posted by FDA

2018-02-21

Terminated

2018-12-13

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0364-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.