Why it was recalled
Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot # 2020A3010, Exp 05/30/2022
Where it was sold
NC and MD
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1586-2020
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 3, 2020
- FDA report date
- Sep 30, 2020
- Quantity
- 28900 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- CORGIOMED LLC
Original FDA data
Every field from FDA enforcement report D-1586-2020, exactly as published.
Show all FDA fields
- City
- Mc Lean
- State
- VA
- Status
- Terminated
- Country
- United States
- Event ID
- 86390
- Address
- 1775 Tysons Blvd Ste 500
- Code information
- Lot # 2020A3010, Exp 05/30/2022
- Postal code
- 22102-4271
- Report date
- Sep 30, 2020
- Product type
- Drugs
- Recall number
- D-1586-2020
- Classification
- Class I
- Recalling firm
- CORGIOMED LLC
- Product quantity
- 28900 bottles
- Termination date
- May 19, 2022
- Reason for recall
- Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- NC and MD
- Recall initiation date
- Sep 3, 2020
- Initial firm notification
- Press Release
- Center classification date
- Sep 18, 2020