Drug & medication recalls Moderate risk

Nanomateriales Sa De Cv recalls Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in a) 33.8 fl oz (1.06 qt) (1L) (NDC 69912-008-01…

Recall date
August 18, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-1592-2020
FDA classification
Class II
Brand / firm
Nanomateriales Sa De Cv
Sold / distributed
CA, NY and Mexico

Why it was recalled

GMP Deviations: Potential to contain 1-propanol.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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