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.
Reported: August 30, 2023 Initiated: August 9, 2023 #D-1100-2023
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.
Reason for Recall
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Details
- Recalling Firm
- Ecometics, Inc.
- Units Affected
- 32,583 bottles
- Distribution
- Nationwide in the USA
- Location
- Norwalk, CT
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ecometics, Inc.. Units affected: 32,583 bottles.
Why was this product recalled? ▼
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 30, 2023. Severity: Moderate. Recall number: D-1100-2023.
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