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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