FDA Drug Class II — Moderate

Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in a) 33.8 fl oz (1.06 qt) (1L) (NDC 69912-008-01 UPC 2 000000 531151); b) 1 gal (3.76L) (NDC 69912-008-02 UPC 2 000000 531144) bottles, Distributed by Fujimura Trading S.A. DE C.V. Juventino Rosas 1902, Col. Caracol, 64810, Monterrey, N.L., Mexico Nanomateriales S.A. DE C.V.

Hazard

GMP Deviations: Potential to contain 1-propanol.

Products

Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in a) 33.8 fl oz (1.06 qt) (1L) (NDC 69912-008-01 UPC 2 000000 531151); b) 1 gal (3.76L) (NDC 69912-008-02 UPC 2 000000 531144) bot
Brand
Nanomateriales Sa De Cv
UPC
All lots

Units Affected

a)19,440 liters b) 25,917 gallon