Drug 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
D-0092-2023
Product summary
- Event
- Event 91272
- Status
- Completed
- Classification
- Class II
- Quantity
- 10,930 gallons
- Official record key
drug-enforcement:D-0092-2023
Official wording
Reason: CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.
Code information: Lots: 12032504, 12014282, 12013501, 12104039, 12013505, 12032523, 12013510, 12014804, 12015401, and 12014113
Distribution pattern: Nationwide in United States and Canada.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations