FDA recall D-0079-2021

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

Product

Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera (ethyl alcohol 70% v/v) 8 fl oz (237 mL) bottle, Distributed by: Midwood brands, LLC 10611 Monroe RD. Mathews, NC 28105 Made in Mexico UPC 3 2251 38042 6

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-0079-2021