Activator Concentrate recalled over manufacturing violations

Recall date

February 24, 2023

Source

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

Official notice title

Ecometics, Inc. recalls Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral rinse plastic bottles, Manufactured fo…

Recall number

D-0451-2023

FDA classification

Class II

Brand / firm

Ecometics, Inc.

Sold / distributed

Nationwide within the United States

Why it was recalled

CGMP DEVIATIONS

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

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