FDA recall D-1593-2020

Product

Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in 25 kg 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. NDC 69912-006-01

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-1593-2020