FDA Drug recall D-1586-2020
Leafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v), Kills 99.99% Germs, EDIBLE ALCOHOL, a) 100 mL bottles, UPC code 697049586…
- FDA Drug
- Class I
- terminated
- Published 2020-09-30
On 2020-09-30 the FDA classified a Class I recall of Leafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v), Kills 99.99% Germs, EDIBLE ALCOHOL, a) 100 mL bottles, UPC code 697049586… by Corgiomed, citing marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1586-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-09-03 |
| Published | 2020-09-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Corgiomed |
| Distribution | MD, NC |
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, McLean, VA 22102, USA, Made in China.
Reason
Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.
Identifiers
| upc | 6970495860325 |
|---|---|
| upc | 6970495860318 |
| upc | 6970495860301 |
| code_info | Lot # 2020A3010, Exp 05/30/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1586-2020%22
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