Recalls / Class II
Class IID-0451-2023
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
- Affected lot / code info
- Lot #: 2E055A, Exp. Date Feb-2025
Why it was recalled
CGMP DEVIATIONS
Recalling firm
- Firm
- Ecometics, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 19 Concord St, Norwalk, Connecticut 06854-3706
Distribution
- Quantity
- 34,320 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2023-02-24
- FDA classified
- 2023-03-08
- Posted by FDA
- 2023-03-15
- Terminated
- 2023-06-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0451-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.