NCH Life Sciences LLC: Drug Recall

Recall #D-0092-2023 · 12/09/2022

Class II: Risk

Recall Details

Recall Number
D-0092-2023
Classification
Class II
Product Type
Drug
Recalling Firm
NCH Life Sciences LLC
Status
Completed
Date Initiated
12/09/2022
Location
Irving, TX, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,930 gallons

Reason for Recall

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

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

Distribution Pattern

Nationwide in United States and Canada.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.