FDA recall D-1360-2022

Aire-Master of America Inc · Class II · drug

Product

Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 08734

Reason for recall

CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.

Distribution

Florida, Illinois, Iowa, New Jersey

Key facts

Status
Terminated
Initiation date
2022-07-15
Report date
2022-08-24
Termination date
2023-02-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Nixa, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1360-2022