FDA recall D-1100-2023

Ecometics, Inc. · Class II · drug

Product

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.

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status: Completed
Initiation date: 2023-08-09
Report date: 2023-08-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Norwalk, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1100-2023