FDA recall D-0639-2024

Zeco LLC · Class II · drug

Product

Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-gallon drum), Sold by: ZEE Company- A Member of the Vincit Group, 3401 Cummings Road, Chattanooga, TN 37419, Made in USA.

Reason for recall

CGMP Deviations: sterile water not used for production

Distribution

Nationwide within the United States and Toronto, Canada (Rubbing alcohol)

Key facts

Status
Completed
Initiation date
2024-08-05
Report date
2024-08-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chattanooga, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0639-2024