# FDA recall D-0598-2021

> **Accupac, Inc.** · Class II · drug recall initiated 2021-05-13.

## Product

Native Fluoride Toothpaste for Sensitive Teeth, with Fluoride, 5% potassium nitrate, 0.243% sodium fluoride (0.14% w/v fluoride ion), Net Wt. 4.1 oz.,116 g, , Distr by Native, San Francisco, CA 94111  NDC: 69423-903-41, UPC 0 37000 28803 9

## Reason for recall

Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free instead of With Fluoride

## Distribution

Naitonwide in the US and Puerto Rico.

## Key facts

- **Recall number:** D-0598-2021
- **Recalling firm:** Accupac, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-05-13
- **Report date:** 2021-06-02
- **Termination date:** 2021-08-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mainland, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0598-2021

## Citation

> AI Analytics. FDA recall D-0598-2021. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-0598-2021. Source: US FDA. Licensed CC0.

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