FDA recall D-1356-2022

Aire-Master of America Inc · Class II · drug

Product

Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 52253

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-1356-2022