The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0451-2023·Announced 2023-03-15

Sodium fluoride oral rinse recalled for manufacturing deviations

Activator Concentrate, a sodium fluoride oral rinse manufactured by Ecometics, Inc., was voluntarily recalled due to manufacturing practice deviations. The recall affected 34,320 bottles distributed nationwide.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall for manufacturing practice deviations with no reported illnesses or injuries. This is a voluntary, precautionary recall.

Plain-English summary

Activator Concentrate is a liquid oral rinse containing sodium fluoride (0.96%), supplied in 1 fl. oz. plastic bottles, manufactured by Ecometics, Inc., for All USA Direct LLC. The recalled product is identified by lot number 2E055A with an expiration date of February 2025.

The manufacturer initiated a voluntary recall due to manufacturing practice deviations, affecting 34,320 bottles distributed nationwide within the United States. The FDA classified this as a Class II recall.

The recall was initiated on February 24, 2023, and was completed on June 21, 2023.

The recalled product

Product
Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral rinse plastic bottles, Manufactured for: All USA Direct LLC, Broadview, IL 60155
Manufacturer
Ecometics, Inc.
Category
Drug — Oral Rinse
Hazard
Affected units
34,320

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 #: 2E055A
  • Exp. Date Feb-2025

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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