FDA recall D-0025-2021

4e Brands North America, Llc · Class II · drug

Product

blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/v), 3.4 fl. oz./100 mL bottle, Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico. UPC 8 14266 02358 7

Reason for recall

CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.

Distribution

Distributed Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2020-07-11
Report date: 2020-10-07
Termination date: 2024-02-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: San Antonio, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0025-2021