PlainRecalls
FDA Drug Moderate Class II Completed

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

Reported: January 4, 2023 Initiated: December 9, 2022 #D-0092-2023

Product Description

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

Reason for Recall

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

Details

Recalling Firm
NCH Life Sciences LLC
Units Affected
10,930 gallons
Distribution
Nationwide in United States and Canada.
Location
Irving, TX

Frequently Asked Questions

What product 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. Recalled by NCH Life Sciences LLC. Units affected: 10,930 gallons.
Why was this product recalled? ▼
CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 4, 2023. Severity: Moderate. Recall number: D-0092-2023.

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