# FDA recall D-1355-2022

> **Aire-Master of America Inc** · Class II · drug recall initiated 2022-07-15.

## 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

- **Recall number:** D-1355-2022
- **Recalling firm:** Aire-Master of America Inc
- **Classification:** Class II
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-1355-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1355-2022. Source: US FDA. Licensed CC0.

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