# FDA recall D-1357-2022

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

## Product

Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440

## 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-1357-2022
- **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-1357-2022

## Citation

> AI Analytics. FDA recall D-1357-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1357-2022. Source: US FDA. Licensed CC0.

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