PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: October 7, 2020 Initiated: July 11, 2020 #D-0025-2021

Product Description

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.

Details

Units Affected
17,359,247 total bottles and pumps
Distribution
Distributed Nationwide in the USA
Location
San Antonio, TX

Frequently Asked Questions

What product was recalled?
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. Recalled by 4e Brands North America, Llc. Units affected: 17,359,247 total bottles and pumps.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 7, 2020. Severity: Moderate. Recall number: D-0025-2021.