Synergy Hand Sanitizer recalled over sterility concerns

Recall date

September 1, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

SUPERIOR GLOVE WORKS, LTD. recalls Synergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria that can potentially cause disease, For use when s…

Recall number

D-1537-2022

FDA classification

Class II

Brand / firm

SUPERIOR GLOVE WORKS, LTD.

Sold / distributed

Nationwide in the US.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.