US Drug Recall Register
Class II · Moderate risk Completed Initiated Aug 9, 2023 (3 years ago)

activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% in diluted…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: Products not manufactured under current good manufacturing practices.

What was recalled

activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% in diluted Activator Solution, Net 1 FL. OZ., Manufactured for: All USA Direct, LLC, Broadview, IL 60155.

Recalling firm
Ecometics, Inc.
Origin
CT, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1100-2023

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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