FDA Recall D-0031-2021

4e Brands North America, Llc · San Antonio, TX

Class I — life-threatening Terminated 1325 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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.

Lot / code: Lot #: a) 2141, Exp 04/40/23; 2879, Exp 04/23/23; 3005, Exp 05/08/23; b) 2911, Exp 04/23/23

Quantity: 17,359,247 total bottles and pumps

Reason for recall

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

Recall record

Recall number: D-0031-2021
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Distributed Nationwide in the USA
Recall initiated: 2020-07-11
Classified by FDA Center: 2020-10-07
FDA published: 2020-10-07
Terminated: 2024-02-26
Recalling firm: 4e Brands North America, Llc
Firm location: San Antonio, TX

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