# FDA recall D-0082-2021

> **Albek De Mexico S.A. De C.V.** · Class II · drug recall initiated 2020-07-30.

## Product

NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ (236 ML) bottle, Made in Mexico, Distributed by: Genomma Lab USA Inc., Houston, TX 77027. UPC 6 50240 05357 3

## Reason for recall

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer 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

USA Nationwide

## Key facts

- **Recall number:** D-0082-2021
- **Recalling firm:** Albek De Mexico S.A. De C.V.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2020-07-30
- **Report date:** 2020-11-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Juan Del Rio, N/A, Mexico

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0082-2021

## Citation

> AI Analytics. FDA recall D-0082-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0082-2021. Source: US FDA. Licensed CC0.

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