Alcohol Antiseptic Hand Sanitizer Recalled for Chemical Contamination
A.P. Nonweiler is recalling its 80% alcohol antiseptic hand sanitizer because FDA testing found acetaldehyde and acetal above safe specification limits. The product was distributed in Wisconsin and Virginia.
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 is an FDA Class II drug recall with no reported illnesses or injuries. The hazard is chemical contamination in a topical application, which qualifies as a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity rating.
Plain-English summary
A.P. Nonweiler Co., Inc. is recalling 833 gallons of its 80% Alcohol Antiseptic Topical Solution, a non-sterile hand sanitizer distributed in Wisconsin and Virginia. The affected product is identified by Lot 54931.
The recall is due to Good Manufacturing Practice deviations. FDA testing found that the product contains acetaldehyde and acetal at levels above the specification limits.
The recalled product is available in two package sizes: 250-gallon totes (Product Code 9999D361-250) and 1-gallon containers (Product Code 9999D361-001).
The recalled product
- Product
- Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-Sterile Solution, Packaged as (a) 250 U.S. gallons per tote, Product Code 9999D361-250: (b) 1 U.S. gallon, Product Code 9999D361-001: A.P. Nonweiler Co., Inc., 3321 County Road A, Oshkosh, WI 54901.
- Manufacturer
- A.P. Nonweiler
- Category
- Drug — Hand Sanitizer
- Hazard
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 (2)
- Lot: 54931
- No Expiration date.
Distribution
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