# FDA recall D-0247-2019

> **Medline Industries Inc** · Class II · drug recall initiated 2018-09-17.

## Product

SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product number NONTP6I), b) 24 g tube (NDC 53329-083-93, product number NONTP85I), c) 42.5 g (NDC 53329-083-21, product number NONTP15I), d) 24 g tube (NDC 53329-081-93, product number DGN1000), Made in Malaysia for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA

## Reason for recall

Microbial Contamination of Non-Sterile Product

## Distribution

Nationwide USA and Puerto Rico

## Key facts

- **Recall number:** D-0247-2019
- **Recalling firm:** Medline Industries Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-09-17
- **Report date:** 2018-11-14
- **Termination date:** 2020-09-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0247-2019

## Citation

> AI Analytics. FDA recall D-0247-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0247-2019. Source: US FDA. Licensed CC0.

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