FDA recall D-1591-2020

GRUPO YACANA MEXICO SAS DE CV · Class II · drug

Product

Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Greensys of North America LLC. 5001 W Military Hwy Ste 100 McAllen, TX USA 78503, NDC# 76562-000-85, UPC 6 64213 64350 0

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-1591-2020