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Recall Observatory FDA recall evidence

Drug 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.

D-0029-2021

July 11, 2020

Class I

Product summary

Firm
4e Brands North America, Llc
Event
Event 86022
Status
Terminated
Classification
Class I
Quantity
17,359,247 total bottles and pumps
Official record key
drug-enforcement:D-0029-2021

Official wording

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

Code information: 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

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Chemical Contamination
  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent