Hand Sanitizer product recalled over sterility concerns

Recall date

April 4, 2022

Source

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

Official notice title

Hand Sanitizer LLC recalls HAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic 80% Topical Non-Sterile Solution, 12 FL OZ (254 mL) bottles, Dis…

Recall number

D-1149-2022

FDA classification

Class II

Brand / firm

Hand Sanitizer LLC

Sold / distributed

Firm failed to provide distribution pattern information.

Why it was recalled

CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal 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

HAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic 80% Topical Non-Sterile Solution, 12 FL OZ (254 mL) bottles, Distributed by: Hand Cleansing Gel 850 Kaliste Saloom Rd. Suite 212 Lafayette, LA 70508 UPC 8 60003 62626 9