Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon bottle (9,464
Summary
The FDA issued a Class II for Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, pa by NCH Life Sciences LLC. Reason: CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits..
Details
Source
Drug Recall
External ID
D-0092-2023
Action Date
2023-01-04
Status
Completed
Category
drug
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
Lot/Code Info: Lots: 12032504, 12014282, 12013501, 12104039, 12013505, 12032523, 12013510, 12014804, 12015401, and 12014113
Quantity Affected: 10,930 gallons
Reason for Recall
CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.
Distribution
Nationwide in United States and Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-09
Company
Irving, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 13 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (NCH Life Sciences LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does NCH Life Sciences LLC have FDA actions?
This is the only FDA action we have on record for NCH Life Sciences LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0092-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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