FDA-Drug2023-08-30Class II
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.
Ecometics, Inc.
Hazard
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Sold states
Nationwide in the USA
Affected count
32,583 bottles
Manufactured in
19 Concord St, N/A, Norwalk, CT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1100-2023Don't want to check this manually?
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