FDA recall D-1590-2020

GRUPO YACANA MEXICO SAS DE CV · Class II · drug

Product

Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Grupo Yacana Mexico SAS de CV Ave. Alfonso reyes 714 Col. Contry La Silla, Monterrey, Nuevo Leon, Mexico Tel. +52 812473-8453, NDC # 76592-002-04, UPC 6 03765 37699 3

Reason for recall

cGMP Deviations

Distribution

TX

Key facts

Status
Terminated
Initiation date
2020-08-18
Report date
2020-09-30
Termination date
2023-05-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Guadalupe, N/A, Mexico

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1590-2020