# FDA recall D-0286-2024

> **Den-Mat Holdings, LLC** · Class II · drug recall initiated 2024-01-16.

## Product

OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA, 93436, USA, NDC 59883-500-01, UPC: 3 59883 00000 4.

## Reason for recall

CGMP Deviations: products may not conform to the labeled specifications.

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0286-2024
- **Recalling firm:** Den-Mat Holdings, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-01-16
- **Report date:** 2024-02-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lompoc, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0286-2024

## Citation

> AI Analytics. FDA recall D-0286-2024. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/D-0286-2024. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
