FDA-Drug2022-08-24Class II

Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum, Fragrance Free, Manufactured for B4 Brands, Lisbon, Iowa 62253

Aire-Master of America Inc
Hazard

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

Sold states
Florida, Illinois, Iowa, New Jersey
Affected count
18 oz bottle: 11,435 bottles; 1000 mL pouch: 4,116 pouches, c) 2 drums
Manufactured in
1821 N State Highway Cc, Nixa, MO, United States
Products
Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum, Fragrance Free, Manufactured for B4 Brands, Lisbon, Iowa 62253

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1355-2022

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