FDA recall D-1537-2022

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

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

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