Recalls / Class II
Class IID-1100-2023
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.
- Affected lot / code info
- Lot: 1E175B, exp 6/24
Why it was recalled
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Recalling firm
- Firm
- Ecometics, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 19 Concord St, N/A, Norwalk, Connecticut 06854-3706
Distribution
- Quantity
- 32,583 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-08-09
- FDA classified
- 2023-08-24
- Posted by FDA
- 2023-08-30
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-1100-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.