SparkleFresh Fluoride Toothpaste recalled over sterility concerns

Recall date

September 17, 2018

Source

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

Official notice title

Medline Industries Inc recalls SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product number NONT…

Recall number

D-0247-2019

FDA classification

Class II

Brand / firm

Medline Industries Inc

Sold / distributed

Nationwide USA and Puerto Rico

Why it was recalled

Microbial Contamination of Non-Sterile Product

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

What was recalled

SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product number NONTP6I), b) 24 g tube (NDC 53329-083-93, product number NONTP85I), c) 42.5 g (NDC 53329-083-21, product number NONTP15I), d) 24 g tube (NDC 53329-081-93, product number DGN1000), Made in Malaysia for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA