Drug & medication recalls Moderate risk

Sage Products Inc recalls Toothette Oral Care Suction Swab System With Antiseptic Oral Rinse and Mouth Moisturizer. Contains 2 Suction Swabs with…

Recall date
August 22, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0368-2018
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 Antiseptic Oral Rinse and Mouth Moisturizer. Contains 2 Suction Swabs with sodium bicarbonate 0.25 fl oz/7ml Antiseptic Oral Rinse 0.7 oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Roarald, Cary, IL 60013. Product Code 6115

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