FDA recall D-1355-2022

Product

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.

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-1355-2022