Product Safety Recalls

Product Recall Tracker

Recall D-1100-2023

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.

Recall D-1100-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-1100-2023
Event ID92857
DistributionNationwide in the USA
Quantity32,583 bottles
Recall ReasonCGMP Deviations: Products not manufactured under current good manufacturing practices.
Drug ClassificationClass II
Drug Code Info20230830
Recall Initiation Date20230809
Report Date20230830
Classification Date20230824
Address19 Concord St
Norwalk, CT 06854-3706
United States
Recalling FirmEcometics, Inc.
Initial Notification Letter
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