# FDA recall D-1581-2020

> **Real Clean Distribuciones SA de CV** · Class II · drug recall initiated 2020-07-23.

## Product

BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), packaged as a) 9.5 FL OZ (280 mL) bottle, UPC 8 40038 21462 4: b) 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3; and c) 34 FL OZ (1L) bottle, UPC 8 40038 21447 1; Made in Mexico; Distributed by Scent Theory Products, LLC, New York, NY 10018.

## Reason for recall

CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-1581-2020
- **Recalling firm:** Real Clean Distribuciones SA de CV
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-07-23
- **Report date:** 2020-09-23
- **Termination date:** 2022-05-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tlalnepantla De Baz, N/A, Mexico

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1581-2020

## Citation

> AI Analytics. FDA recall D-1581-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1581-2020. Source: US FDA. Licensed CC0.

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