NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER recalled over manufacturing violations

Recall date

July 30, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Albek De Mexico S.A. De C.V. recalls NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ (236 ML) bottle, Made in Mexico, Distributed by…

Recall number

D-0082-2021

FDA classification

Class II

Brand / firm

Albek De Mexico S.A. De C.V.

Sold / distributed

USA Nationwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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