December 2022 FDA Recall Drug by Nch Life Sciences Llc
D-0092-2023 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Nch Life Sciences Llc on December 9, 2022 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently completed.

Recall Number: D-0092-2023

Reason for Recall
CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.
Initiated
12-09-2022
Reported
01-04-2023
Quantity
10,930 gallons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91272
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
NCH Life Sciences LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in United States and Canada.
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# Lots: 12032504, 12014282, 12013501, 12104039, 12013505, 12032523, 12013510, 12014804, 12015401, and 12014113