Drug product
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
D-0451-2023
Product summary
- Firm
- Ecometics, Inc.
- Event
- Event 91719
- Status
- Terminated
- Classification
- Class II
- Quantity
- 34,320 bottles
- Official record key
drug-enforcement:D-0451-2023
Official wording
Reason: CGMP DEVIATIONS
Code information: Lot #: 2E055A, Exp. Date Feb-2025
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP DEVIATIONS