Stage 2-Ophardt Foaming Hand Sanitizer recalled over manufacturing violations

Recall date

July 15, 2022

Source

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

Official notice title

Aire-Master of America Inc recalls Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corpora…

Recall number

D-1357-2022

FDA classification

Class II

Brand / firm

Aire-Master of America Inc

Sold / distributed

Florida, Illinois, Iowa, New Jersey

Why it was recalled

CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.

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

What was recalled

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