PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 24, 2022 Initiated: July 15, 2022 #D-1355-2022

Product Description

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

Reason for Recall

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

Details

Units Affected
18 oz bottle: 11,435 bottles; 1000 mL pouch: 4,116 pouches, c) 2 drums
Distribution
Florida, Illinois, Iowa, New Jersey
Location
Nixa, MO

Frequently Asked Questions

What product was recalled?
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. Recalled by Aire-Master of America Inc. Units affected: 18 oz bottle: 11,435 bottles; 1000 mL pouch: 4,116 pouches, c) 2 drums.
Why was this product recalled?
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 24, 2022. Severity: Moderate. Recall number: D-1355-2022.