US Drug Recall Register
Class II · Moderate risk Terminated Initiated Feb 24, 2023 (4 years ago)

Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral rinse…

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

Why it was recalled

CGMP DEVIATIONS

What was recalled

Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral rinse plastic bottles, 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-0451-2023

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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