Why it was recalled
Lack of CGMPs:
Product description
V-Klean Hand Sanitizer Gel Alcohol 70% packaged as a)8.5 fl oz (250 ml), UPC 7 16053 70499 3; b) 16.9 fl oz (500 ml), UPC 7 16053 70499 3; c) 33.8 fl. oz. (1000 ml) bottles: 716053704993; Manufactured by: Asiaticon S.A. de C.V. Conkar 62, Jardines del Ajusco. Tlalpan Cuidad de Mexico. 14200 ;
Lot numbers, UPCs & expiration codes
All lots.
Where it was sold
Distributed in Texas
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-0116-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 25, 2020
- FDA report date
- Dec 16, 2020
- Quantity
- 111,500 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Asiaticon, SA de CV
Original FDA data
Every field from FDA enforcement report D-0116-2021, exactly as published.
Show all FDA fields
- City
- Ciudad De Mexico
- Status
- Terminated
- Country
- Mexico
- Event ID
- 86327
- Address
- Conkal No. 62
- Code information
- All lots.
- Report date
- Dec 16, 2020
- Product type
- Drugs
- Recall number
- D-0116-2021
- Classification
- Class II
- Recalling firm
- Asiaticon, SA de CV
- Product quantity
- 111,500 units
- Termination date
- May 17, 2023
- Reason for recall
- Lack of CGMPs:
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- V-Klean Hand Sanitizer Gel Alcohol 70% packaged as a)8.5 fl oz (250 ml), UPC 7 16053 70499 3; b) 16.9 fl oz (500 ml), UPC 7 16053 70499 3; c) 33.8 fl. oz. (1000 ml) bottles: 716053704993; Manufactured by: Asiaticon S.A. de C.V. Conkar 62, Jardines del Ajusco. Tlalpan Cuidad de Mexico. 14200 ;
- Distribution pattern
- Distributed in Texas
- Recall initiation date
- Aug 25, 2020
- Initial firm notification
- Press Release
- Center classification date
- Dec 7, 2020