Drug & medication recalls Moderate risk

Accupac, Inc. recalls Native Fluoride Toothpaste for Sensitive Teeth, with Fluoride, 5% potassium nitrate, 0.243% sodium fluoride (0.14% w/v…

Recall date
May 13, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0598-2021
FDA classification
Class II
Brand / firm
Accupac, Inc.
Sold / distributed
Naitonwide in the US and Puerto Rico.

Why it was recalled

Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free instead of With Fluoride

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

What was recalled

Native Fluoride Toothpaste for Sensitive Teeth, with Fluoride, 5% potassium nitrate, 0.243% sodium fluoride (0.14% w/v fluoride ion), Net Wt. 4.1 oz.,116 g, , Distr by Native, San Francisco, CA 94111 NDC: 69423-903-41, UPC 0 37000 28803 9

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