Alcohol Antiseptic 80% Topical Solution Hand Sanitizer recalled over sterility concerns

Recall date

December 9, 2022

Source

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

Official notice title

NCH Life Sciences LLC recalls Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon bottle (9,464…

Recall number

D-0092-2023

FDA classification

Class II

Brand / firm

NCH Life Sciences LLC

Sold / distributed

Nationwide in United States and Canada.

Why it was recalled

CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed 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

Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon bottle (9,464 ml), NDC 55533-524-02, and b) 55 gallon bottle (208,198 ml), NDC 55533-524-03, Manufactured for: Multi-Mist Products A Division of NCH Corporation 1618 Northgate, Irving, Texas 75062