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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-1100-2023 |
Event ID | 92857 |
Distribution | Nationwide in the USA |
Quantity | 32,583 bottles |
Recall Reason | CGMP Deviations: Products not manufactured under current good manufacturing practices. |
Drug Classification | Class II |
Drug Code Info | 20230830 |
Recall Initiation Date | 20230809 |
Report Date | 20230830 |
Classification Date | 20230824 |
Address | 19 Concord St Norwalk, CT 06854-3706 United States |
Recalling Firm | Ecometics, Inc. |
Initial Notification | Letter |
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