Alcohol-Free Hand Sanitizer Recalled for Microbial Contamination
HLI dba Humphreyline Inc is recalling 975 bottles of alcohol-free hand sanitizer due to microbial contamination. The product was distributed in Kentucky, Maryland, 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 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: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. Per the rubric, a Class II recall without reported adverse health consequences is typically scored as Moderate (2) or High (3); given the lack of reported harm and the specific nature of the contamination in a non-sterile product, Moderate is appropriate.
Plain-English summary
HLI dba Humphreyline Inc is recalling 975 bottles of Alcohol-Free Hand Sanitizer, 1 fl. oz. (30 ml), due to microbial contamination of a non-sterile product. The product is an over-the-counter item containing Benzalkonium chloride, manufactured for HLI in Portland, Oregon. It is labeled for Anne Arundel County Mental Health Agency, Inc., Family Advocacy Program, and Henderson Community College Nursing.
The recalled product is identified by Lot # MB140417 and has an expiration date of 04/2017. The bottles are capped with a white sprayer. The recall number is D-1518-2014.
The product was distributed in Kentucky, Maryland, and Virginia. Consumers should stop using the product and contact the recalling firm for instructions on disposal or return.
The recalled product
- Product
- Alcohol-Free Hand Sanitizer, 1. fl. oz. (30 ml) bottles capped with white sprayer, OTC, contains Benzalkonium chloride. Mfg. for HLI, Portland, OR 97222 NDC: 19392-120-03. Labeled A) Anne Arundel County Mental Health Agency, Inc., B) Family Advocacy Program, and C) Henderson…
- Manufacturer
- HLI dba Humphreyline Inc
- Category
- Drug — Over-the-Counter (OTC)
- Hazard
- Affected units
- 975
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 #: MB140417
- Expiry: 04/2017.
Distribution
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