Why it was recalled
CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed lots of product.
Product description
bio aaa Alcohol en Gel Antibacterial, Alcohol al 70% Cont. Neto 480 ml bottle, Hecho en Mexico por: AAA Cosmetica S.A. DE C.V. Recursos Hidraulicos No. 1 Secc. A, Col La Loma Zona Industrial, Tlalnepantla de Baz C.P. 54060 Edo. Mexico. UPC 7 502272 12108 5
Lot numbers, UPCs & expiration codes
Lot: 20DF8307 Exp. 04/2022
Where it was sold
Distributed in Florida
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-1620-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 3, 2020
- FDA report date
- Sep 30, 2020
- Quantity
- 2000 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AJR TRADING LLC
Original FDA data
Every field from FDA enforcement report D-1620-2020, exactly as published.
Show all FDA fields
- City
- Coral Gables
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 86388
- Address
- 814 Ponce De Leon Blvd Ste 218
- Code information
- Lot: 20DF8307 Exp. 04/2022
- Postal code
- 33134-3032
- Report date
- Sep 30, 2020
- Product type
- Drugs
- Recall number
- D-1620-2020
- Classification
- Class II
- Recalling firm
- AJR TRADING LLC
- Product quantity
- 2000 bottles
- Termination date
- Oct 4, 2023
- Reason for recall
- CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed lots of product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- bio aaa Alcohol en Gel Antibacterial, Alcohol al 70% Cont. Neto 480 ml bottle, Hecho en Mexico por: AAA Cosmetica S.A. DE C.V. Recursos Hidraulicos No. 1 Secc. A, Col La Loma Zona Industrial, Tlalnepantla de Baz C.P. 54060 Edo. Mexico. UPC 7 502272 12108 5
- Distribution pattern
- Distributed in Florida
- Recall initiation date
- Sep 3, 2020
- Initial firm notification
- Press Release
- Center classification date
- Sep 24, 2020