Recalls / Class II

Class IID-0382-2018

Product

Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. Contains 2 Suction Toothbrushes with sodium bicarbonate, 0.25 fl oz/7ml Perox-A-Mint solution. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6570

Affected lot / code info

Product Code: 6570; Lots: 51571, EXP 08/15/2017; 52105, EXP 09/19/2017; 53077, EXP 11/14/2017; 54259, EXP 02/06/2018; 55243, 04/10/2018; 56167, EXP 06/12/2018; 56874, EXP 07/31/2018; 57748, EXP 09/18/2018; 59258, EXP 11/20/2018; 60144, EXP 11/27/2018; 61149, EXP 03/26/2019; 62084, EXP 05/14/2019.

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

6472 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-0382-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.