FDA recall D-0031-2021

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

Product

blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) Packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266 02359 4, b) 7.5 fl oz / 221 ml bottle, UPC 8 14266 02362 4, Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico.

Reason for recall

Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.

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-0031-2021