FDA-Drug2023-03-15Class II

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

Ecometics, Inc.
Hazard

CGMP DEVIATIONS

Sold states
Nationwide within the United States
Affected count
34,320 bottles
Manufactured in
19 Concord St, Norwalk, CT, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0451-2023

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