FDA recall D-0082-2021

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

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

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-0082-2021