FDA recall D-0080-2021

Albek De Mexico S.A. De C.V. · Class II · drug

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0080-2021