# FDA recall D-0022-2021

> **4e Brands North America, Llc** · Class II · drug recall initiated 2020-07-11.

## Product

blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost with Tea Tree Oil, (70% ethyl alcohol), Packaged as a) 18 fl oz / 532 ml bottle, UPC 8 14266 02408 9 b) 33.8 fl oz / 1L bottle, UPC  8 14266 02374 7, Distributed in USA and Canada BY: 4e Brands Northamerica LLC. 17806 IH-10W, Suite 300, San Antonio, Texas, 78257. Made in Mexico.

## Reason for recall

CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0022-2021
- **Recalling firm:** 4e Brands North America, Llc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-07-11
- **Report date:** 2020-10-07
- **Termination date:** 2024-02-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Antonio, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0022-2021

## Citation

> AI Analytics. FDA recall D-0022-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0022-2021. Source: US FDA. Licensed CC0.

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