FDA Recall D-0029-2021

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 Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 6 b) 17 fl oz / 503 ml bottle with blue cap or pump bottle, UPC 8 14266 02409 6 c) 33.8 fl oz / 1 L straight or curved bottle, UPC 8 14266 02369 3. 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 04/04/23; 3005, Exp 05/08/23; b) 3005, Exp 05/08/23; 2879, 2892, 2911, Exp 4/23/23; 2515, Exp 4/20/23; 3270, Exp 5/09/23; c) 3095, Exp 05/07/23; 2839, Exp 04/20/23; 2879, Exp 04/23/23; 2894, Exp 04/27/23

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-0029-2021
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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