Why it was recalled
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Product 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.
Lot numbers, UPCs & expiration codes
Lot: 1E175B, exp 6/24
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1100-2023
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Aug 9, 2023
- FDA report date
- Aug 30, 2023
- Quantity
- 32,583 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ecometics, Inc.
Original FDA data
Every field from FDA enforcement report D-1100-2023, exactly as published.
Show all FDA fields
- City
- Norwalk
- State
- CT
- Status
- Completed
- Country
- United States
- Event ID
- 92857
- Address
- 19 Concord St
- Code information
- Lot: 1E175B, exp 6/24
- Postal code
- 06854-3706
- Report date
- Aug 30, 2023
- Product type
- Drugs
- Recall number
- D-1100-2023
- Classification
- Class II
- Recalling firm
- Ecometics, Inc.
- Product quantity
- 32,583 bottles
- Reason for recall
- CGMP Deviations: Products not manufactured under current good manufacturing practices.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 9, 2023
- Initial firm notification
- Letter
- Center classification date
- Aug 24, 2023