# FDA recall D-0363-2022

> **Valisa MFG LLC** · Class I · drug recall initiated 2021-12-06.

## Product

kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles, Distributed by: Valisa MFG, LLC, Farmingdale, NY, 11735, Made in USA, UPC 6 86162 99246 1

## Reason for recall

Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0363-2022
- **Recalling firm:** Valisa MFG LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-12-06
- **Report date:** 2022-01-05
- **Termination date:** 2024-02-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Farmingdale, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0363-2022

## Citation

> AI Analytics. FDA recall D-0363-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0363-2022. Source: US FDA. Licensed CC0.

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