Global Hand Sanitizer with moisturizer recalled over sterility concerns

Recall date

June 30, 2021

Source

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

Official notice title

Cascade Kelly Holdings LLC recalls Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 4 fl. oz./119 mL, A…

Recall number

D-0697-2021

FDA classification

Class II

Brand / firm

Cascade Kelly Holdings LLC

Sold / distributed

Distributed to the firm's affiliated facilities and donated third party recipients located in the following states: CT, MA, ME, ND, NY, OR, PA, TX, VT.

Why it was recalled

CGMP Deviations: Does not meet monograph for denaturant.

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

What was recalled

Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 4 fl. oz./119 mL, Alcohol 80% v/v, Manufactured by: Cascade Kelly Holdings LLC, NDC 80253-001-01