Recalls / Class II

Class IID-0383-2018

Product

Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. Contains 1 Suction toothbrush with sodium bicarbonate, 0.25 fl oz /7ml Perox-A-Mint solution. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6571

Affected lot / code info

Product Code: 6571; Lots: 52384, EXP 10/03/2018; 53134, EXP 11/28/2017; 53387, EXP 12/05/2017; 54215, EXP 02/06/2018; 54967, EXP 03/28/2018; 55997, EXP 05/30/2018; 56180, EXP 06/12/2018; 56854, EXP 07/31/2018; 57334, EXP 08/21/2018; 58305, EXP 10/16/2018; 59844, EXP 01/08/2019; 60753, 60761, 60772, 60780, 60788,EXP 03/05/2019; 61664, EXP 04/23/2019; 62156, 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

8466 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-0383-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.