PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: March 15, 2023 Initiated: February 24, 2023 #D-0451-2023

Product Description

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

Reason for Recall

CGMP DEVIATIONS

Details

Recalling Firm
Ecometics, Inc.
Units Affected
34,320 bottles
Distribution
Nationwide within the United States
Location
Norwalk, CT

Frequently Asked Questions

What product was recalled?
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. Recalled by Ecometics, Inc.. Units affected: 34,320 bottles.
Why was this product recalled?
CGMP DEVIATIONS
Which agency issued this recall?
This recall was issued by the FDA Drug on March 15, 2023. Severity: Moderate. Recall number: D-0451-2023.