Ecometics, Inc.: Drug Recall

Recall #D-1100-2023 · 08/09/2023

Class II: Risk

Recall Details

Recall Number
D-1100-2023
Classification
Class II
Product Type
Drug
Recalling Firm
Ecometics, Inc.
Status
Completed
Date Initiated
08/09/2023
Location
Norwalk, CT, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
32,583 bottles

Reason for Recall

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

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.

Distribution Pattern

Nationwide in the USA

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.