Cleaning Solutions Foaming Hand Sanitizer Recalled for Skin Irritation Risk
Sanitor Corporation is recalling Cleaning Solutions Foaming Hand Sanitizer (Benzalkonium chloride 0.1%) due to contamination from Current Good Manufacturing Practice (CGMP) deviations. Use may cause skin or soft tissue infection and irritation.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for a manufacturing deviation in a topical product. No illnesses or injuries have been reported in the source text, and the hazard is theoretical skin irritation rather than a known high-risk pathogen. This fits the Class II classification without hospitalization reports, corresponding to a Moderate severity level.
Plain-English summary
Sanitor Corporation is recalling Cleaning Solutions Foaming Hand Sanitizer containing Benzalkonium chloride 0.1%. The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified during production.
Use of this product may cause possible infection or irritation of the skin and soft tissues. The product was distributed to one distributor located in Las Vegas, Nevada.
Consumers who have purchased this product should discontinue use. Affected lot numbers are 20102 and 20103, with an expiration date of September 2021. The product is identified by UPC# 8 60001 93396 3.
The recalled product
- Product
- Cleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chloride 0.1%, New Wave Cleaning Solutions LLC, 7001 W Arby Ave Suite 100, Las Vegas, NV 89113, UPC#: 8 60001 93396 3
- Manufacturer
- Sanitor Corporation
- Category
- Drug — Hand Sanitizer
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 (5)
- Lot # 20102
- 20103
- Exp
- Sept
- 2021
Distribution
Distributed in 1 state:
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