Drug & medication recalls Moderate risk

Activator concentrate recalled over manufacturing violations

Recall date
August 9, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Ecometics, Inc. recalls activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% in diluted Activator Solution, Net 1 FL. O…
Recall number
D-1100-2023
FDA classification
Class II
Brand / firm
Ecometics, Inc.
Sold / distributed
Nationwide in the USA

Why it was recalled

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

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

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