# FDA recall D-0033-2021

> **Volu-Sol, Inc.** · Class I · drug recall initiated 2020-08-14.

## Product

Volu-Sol Handrub Sanitizing Solution (Ethyl Alcohol, 69% v/v and Isopropyl Alcohol, 7.2% v/v) Topical Solution, 473 mL/ 16 fl oz bottle, Vou-Sol 5095 W 2100 S, Salt Lake City, UT 84120, NDC 74401-800-16

## Reason for recall

Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.

## Distribution

Sold to one distributor located in CA and one hospital system located in UT.

## Key facts

- **Recall number:** D-0033-2021
- **Recalling firm:** Volu-Sol, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-08-14
- **Report date:** 2020-10-07
- **Termination date:** 2024-02-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Salt Lake City, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0033-2021

## Citation

> AI Analytics. FDA recall D-0033-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0033-2021. Source: US FDA. Licensed CC0.

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