Hand Sanitizer Recalled for Excess Chemical Impurities in Manufacturing
NCH Life Sciences LLC is recalling hand sanitizer products containing excess acetal and acetaldehyde impurities due to manufacturing deviations. The recall affects 2.5 and 55-gallon bottles distributed nationwide in the US and Canada.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves chemical impurities in a topical antiseptic product where no illnesses or injuries have been reported. The product constitutes a risk-of-harm due to excess acetal and acetaldehyde impurities, meeting the criteria for High severity.
Plain-English summary
NCH Life Sciences LLC is recalling Alcohol Antiseptic 80% Topical Solution Hand Sanitizer in non-sterile form. The affected products include 2.5-gallon bottles (NDC 55533-524-02) and 55-gallon bottles (NDC 55533-524-03), representing approximately 10,930 gallons of product.
The recall is due to Current Good Manufacturing Practice (CGMP) deviations. Testing revealed impurities of acetal and acetaldehyde in the product in excess of allowed limits.
The product was distributed nationwide in the United States and Canada. Consumers and facilities using affected lots (12032504, 12014282, 12013501, 12104039, 12013505, 12032523, 12013510, 12014804, 12015401, and 12014113) should discontinue use immediately. Contact the manufacturer or the FDA for further information.
The recalled product
- 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…
- Manufacturer
- NCH Life Sciences LLC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Lots: 12032504
- 12014282
- 12013501
- 12104039
- 12013505
- 12032523
- 12013510
- 12014804
- 12015401
- and 12014113
Distribution
Distributed nationwide across the United States.
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