Sage Products Inc recalls Toothette Oral Care Suction Swab System with Perox-A-Mint Solution, Contains 6 Packages of 2 Suction Swabs with sodium,…

Recall date

August 22, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0380-2018

FDA classification

Class II

Brand / firm

Sage Products Inc

Sold / distributed

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

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Toothette Oral Care Suction Swab System with Perox-A-Mint Solution, Contains 6 Packages of 2 Suction Swabs with sodium, bicarbonate and a .25 fl oz/7ml pouch of Perox-A-Mint solution, 10 Applicator Swabs, .5 oz/14g tube of Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6550 6 18029 80065 7