Recalls / Class I

Class ID-0029-2021

Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.

Affected lot / code info: 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

Why it was recalled

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

Recalling firm

Firm: 4e Brands North America, Llc
Notification channel: Press Release
Type: Voluntary: Firm initiated
Address: 17806 Ih-10 Ste 300, N/A, San Antonio, Texas 78257

Distribution

Quantity: 17,359,247 total bottles and pumps
Distribution pattern: Distributed Nationwide in the USA

Timeline

Recall initiated: 2020-07-11
FDA classified: 2020-10-07
Posted by FDA: 2020-10-07
Terminated: 2024-02-26
Status: Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0029-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.