Reported Nov 14, 2018 · Terminated

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

Medline Industries Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medline Industries Inc · Three Lakes Drive · Northfield, IL · 60093

Is this the product you have?

4 of 4 products

Products covered by this recall
Model / numberProduct as published
NONTP6I17 g tube (NDC 53329-083-92, )
NONTP85I24 g tube (NDC 53329-083-93, )
NONTP15I42.5 g (NDC 53329-083-21, )
DGN100024 g tube (NDC 53329-081-93, ), Made in Malaysia for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA
Lot codes and dates
    • a) Lot 102920C
    • exp 10/29/2020 and 111220C
    • exp 11/11/2020
    • b) 111620D
    • exp 11/16/2020
    • c) 111420D
    • exp 11/14/2020
    • d) 111720C
    • exp 11/17/2020
Amount recalled
994,756 tubes

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Microbial Contamination of Non-Sterile Product

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 4, 2020 · Data as of Sep 19, 7:22 PM UTC

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