PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: November 25, 2020 Initiated: July 30, 2020 #D-0082-2021

Product Description

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.

Details

Units Affected
4,598,788 bottles
Distribution
USA Nationwide
Location
San Juan Del Rio, N/A

Frequently Asked Questions

What product 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. Recalled by Albek De Mexico S.A. De C.V.. Units affected: 4,598,788 bottles.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 25, 2020. Severity: Moderate. Recall number: D-0082-2021.