# FDA recall D-1537-2022

> **SUPERIOR GLOVE WORKS, LTD.** · Class II · drug recall initiated 2022-09-01.

## Product

Synergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria that can potentially cause disease, For use when soap and water are not available, Alcohol 80% Topical Solution, Antiseptic, 8.5 oz./ 250 mL bottles, Made and Distributed by: Superior Glove Works Ltd., 36 Vimy Street, Acton, Ontario, L7J 1S1, Canada, Made in Canada, UPC: 779406201594.

## Reason for recall

CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.

## Distribution

Nationwide in the US.

## Key facts

- **Recall number:** D-1537-2022
- **Recalling firm:** SUPERIOR GLOVE WORKS, LTD.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-09-01
- **Report date:** 2022-09-21
- **Termination date:** 2023-06-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Acton, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1537-2022

## Citation

> AI Analytics. FDA recall D-1537-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1537-2022. Source: US FDA. Licensed CC0.

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