Drug product
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.
D-1100-2023
Product summary
- Firm
- Ecometics, Inc.
- Event
- Event 92857
- Status
- Completed
- Classification
- Class II
- Quantity
- 32,583 bottles
- Official record key
drug-enforcement:D-1100-2023
Official wording
Reason: CGMP Deviations: Products not manufactured under current good manufacturing practices.
Code information: Lot: 1E175B, exp 6/24
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations