FDA recall D-0778-2021

Product

MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alcohol 70% v/v), 10 FL OZ / 300 mL, Manufactured by Grupo V-Klean S.A. de C.V, Calle Alborada 124, Parques del Pedregal, Tlalpan, 14250 Ciudad de Mexico, CDMX, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC: 6 76753 00417 8

Reason for recall

CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

Distribution

Product Distributed Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2021-05-12

Report date

2021-09-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Las Vegas, NV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0778-2021