FDA-Drug2023-01-04Class II

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

NCH Life Sciences LLC
Hazard

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

Sold states
Nationwide in United States and Canada.
Affected count
10,930 gallons
Manufactured in
2730 Carl Rd, Irving, TX, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0092-2023

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