Why it was recalled
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Product description
kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles, Distributed by: Valisa MFG, LLC, Farmingdale, NY, 11735, Made in USA, UPC 6 86162 99246 1
Lot numbers, UPCs & expiration codes
Lot #: 1260-1, 1260-2, 1260-3, 1260-4. Exp. 04/2022
Where it was sold
Nationwide in the USA
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-0363-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 6, 2021
- FDA report date
- Jan 5, 2022
- Quantity
- 7704 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Valisa MFG LLC
Original FDA data
Every field from FDA enforcement report D-0363-2022, exactly as published.
Show all FDA fields
- City
- Farmingdale
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 89186
- Address
- 131 Executive Blvd
- Code information
- Lot #: 1260-1, 1260-2, 1260-3, 1260-4. Exp. 04/2022
- Postal code
- 11735-4719
- Report date
- Jan 5, 2022
- Product type
- Drugs
- Recall number
- D-0363-2022
- Classification
- Class I
- Recalling firm
- Valisa MFG LLC
- Product quantity
- 7704 bottles
- Termination date
- Feb 26, 2024
- Reason for recall
- Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles, Distributed by: Valisa MFG, LLC, Farmingdale, NY, 11735, Made in USA, UPC 6 86162 99246 1
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Dec 6, 2021
- Initial firm notification
- Letter
- Center classification date
- Jan 10, 2022