Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2....
FDA Recall #D-0092-2023 — Class II — December 9, 2022
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.
Recalling Firm
NCH Life Sciences LLC — Irving, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
10,930 gallons
Distribution
Nationwide in United States and Canada.
Code Information
Lots: 12032504, 12014282, 12013501, 12104039, 12013505, 12032523, 12013510, 12014804, 12015401, and 12014113
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated