# FDA recall D-0453-2022

> **Dental Alliance Holdings LLC** · Class III · drug recall initiated 2021-12-03.

## Product

CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321   Distributed in 12-pk/cases

## Reason for recall

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

## Distribution

Distributed nationwide with the United States

## Key facts

- **Recall number:** D-0453-2022
- **Recalling firm:** Dental Alliance Holdings LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-12-03
- **Report date:** 2022-02-02
- **Termination date:** 2022-08-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Albany, OR, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0453-2022

## Citation

> AI Analytics. FDA recall D-0453-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0453-2022. Source: US FDA. Licensed CC0.

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