FDAFDA · Food and drugs·Recall number D-1100-2023
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.
Published August 30, 2023 · Recall initiated: August 9, 2023
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Products not manufactured under current good manufacturing practices.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ecometics, Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot: 1E175B, exp 6/24
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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