# FDA recall D-0080-2021

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

## Product

Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 fl oz / 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico.UPC 639277928610

## 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-0080-2021
- **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-0080-2021

## Citation

> AI Analytics. FDA recall D-0080-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0080-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*