FDA recall D-0640-2024

Product

HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4x1 gallon jugs), b) 18.92L (5-gallon pail), c) 208.19L (55-gallon drum), and d) 1040.98L (275-gallon tote), ZEE Company 3401 Cummings Road, Chattanooga, TN, 37419, NDC 86161-210

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-0640-2024