Leiper's Fork Distillery Recalls Alcohol Antiseptic Topical Solution Due to Methanol Labeling
Leiper's Fork Distillery is recalling 1,996 gallons of 70% Ethyl Alcohol Antiseptic Topical Solution because the product is labeled to contain methanol.
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 and involves a labeling error regarding methanol content. Per the rubric, minor labeling errors and low-risk contamination fall under the Moderate severity category.
Plain-English summary
Leiper's Fork Distillery is recalling 1,996 gallons of Alcohol Antiseptic Topical Solution, Ethyl Alcohol 70%. The product is packaged in 16 fluid ounce bottles and 5-gallon vacuum-sealed buckets. The recall covers all lots of the product.
The recall was initiated because the product is labeled to contain methanol. This labeling issue is classified by the FDA as 'Labeling Not Elsewhere Classified.' The product was distributed in Tennessee.
Consumers who have this product should stop using it and contact the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- Leiper's Fork Distillery, Alcohol Antiseptic Topical Solution, Ethyl Alcohol 70%, packaged as a) 16 fluid oz./473.18 mL, bottle. b) 5 gallon vacuum sealed bucket. Leiper's Fork Distillery
- Manufacturer
- Leiper's Fork Distillery
- Category
- Drug — Topical Antiseptic
- 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 (1)
- All Lots
Distribution
Distributed in 1 state:
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