MEDEK LLC recalls M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,785 mL, Made in Mexico by: Grupo Plast-Y-Ko…

Recall date

September 9, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1342-2022

FDA classification

Class I

Brand / firm

MEDEK LLC

Sold / distributed

Texas

Why it was recalled

Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,785 mL, Made in Mexico by: Grupo Plast-Y-Kosas S.A. de C.V. Puebla 105 Col. Rodriguez Reynosa, Tam, Mexico C.P. 88630, NDC Code: 77797-001-01, Distributed by: Medek, LLC 315 E. Business Hwy 83 Alamo, TX 78516, NDC Code: 75432-001-02.