activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% in diluted Activator...
FDA Recall #D-1100-2023 — Class II — August 9, 2023
Product Description
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.
Recalling Firm
Ecometics, Inc. — Norwalk, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
32,583 bottles
Distribution
Nationwide in the USA
Code Information
Lot: 1E175B, exp 6/24
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated