Leafree Hand Sanitizer Recalled for Lacking FDA Approval
Corgiomed LLC is recalling Leafree Instant Hand Sanitizer because it was marketed without FDA approval and labeled as edible alcohol.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Corgiomed LLC is recalling Leafree Instant Hand Sanitizer Aloe Vera in 100 mL, 300 mL, and 500 mL bottles. The product is identified by Lot # 2020A3010 and an expiration date of 05/30/2022. A total of 28,900 bottles were distributed in North Carolina and Maryland.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product was labeled as "Edible Alcohol," which renders it an unapproved new drug and misbranded under FDA regulations.
Consumers who have purchased this product should stop using it and contact the distributor for further instructions.
The recalled product
- Product
- Leafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v), Kills 99.99% Germs, EDIBLE ALCOHOL, a) 100 mL bottles, UPC code 6970495860325, b) 300 mL bottles, UPC code 6970495860318, and c) 500 mL bottles, UPC code 6970495860301, Exclusively Distributed by: Corgiomed LLC…
- Manufacturer
- CORGIOMED LLC
- Category
- Drug — Hand Sanitizer
- Affected units
- 28,900
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 # 2020A3010
- Exp 05/30/2022
Distribution
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