D-0092-2023 Class II
FDA drug recall D-0092-2023 was initiated by NCH Life Sciences LLC on December 9, 2022 and is designated Class II. Reason for recall: CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits. Affected quantity: 10,930 gallons.
Recall Details
- Product Type
- Drugs
- Report Date
- January 4, 2023
- Initiation Date
- December 9, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,930 gallons
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.
Distribution Pattern
Nationwide in United States and Canada.
Code Information
Lots: 12032504, 12014282, 12013501, 12104039, 12013505, 12032523, 12013510, 12014804, 12015401, and 12014113