The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1100-2023·Announced 2023-08-30

Sodium Fluoride Activator Concentrate Recalled for Manufacturing Practice Violations

Ecometics, Inc. is recalling 32,583 bottles of Sodium Fluoride 0.96% Activator Concentrate nationwide due to manufacturing practice deviations. The product was not manufactured under current good manufacturing practices (CGMP).

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall due to manufacturing practice deviations. The product was not manufactured under Current Good Manufacturing Practices (CGMP), which constitutes a potential risk of harm to consumers by affecting product quality, purity, and safety assurance. No illnesses or injuries have been reported. Per the rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' warranting a High (3) classification.

Plain-English summary

Ecometics, Inc. is recalling 32,583 bottles of Sodium Fluoride 0.96% Activator Concentrate (Net 1 FL. OZ., Lot 1E175B, expiration 6/24) due to Current Good Manufacturing Practice (CGMP) deviations. The product, manufactured for All USA Direct, LLC in Broadview, Illinois, was not produced under CGMP requirements, which establish the standards for quality, purity, and safety in pharmaceutical manufacturing.

The affected product was distributed nationwide in the United States. The recalled lot number is 1E175B with an expiration date of 6/24.

Consumers who have purchased this product should stop using it and consult their healthcare provider or dentist regarding any previous use. Consumers should dispose of the product safely or return it to the point of purchase.

The recalled product

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.
Manufacturer
Ecometics, Inc.
Category
Drug — Dental / Fluoride
Hazard
Affected units
32,583

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: 1E175B
  • exp 6/24

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Ecometics, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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