FDA recall D-1592-2020

Product

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.

Reason for recall

GMP Deviations: Potential to contain 1-propanol.

Distribution

CA, NY and Mexico

Key facts

Status

Terminated

Initiation date

2020-08-18

Report date

2020-09-30

Termination date

2024-07-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ciudad Apodaca, N/A, Mexico

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1592-2020