Drug & medication recalls Moderate risk

Sage Products Inc recalls Toothette Oral Care Short Term Oral Swab System with Antiseptic Oral Rinse, Contains 20 Toothette Plus Oral Swabs with…

Recall date
August 22, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0367-2018
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 Short Term Oral Swab System with Antiseptic Oral Rinse, Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl oz/44ml bottle of Antiseptic Oral Rinse, .5 oz.14g tube of Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6100 UPC (01)00618029820969

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