FDA recall D-0384-2018

Product

Toothette Oral Care Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer. Contains 1 Suction Toothbrush with sodium Bicarbonate, 0.25 fl oz /7ml Perox-A-Mint solution, 0.07 oz/2g Mouth Moisturizer, 1 Applicator Swab, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6572

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-08-22

Report date

2018-02-21

Termination date

2018-12-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cary, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0384-2018