D-0363-2022 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 5, 2022
- Initiation Date
- December 6, 2021
- Termination Date
- February 26, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7704 bottles
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
Reason for Recall
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 1260-1, 1260-2, 1260-3, 1260-4. Exp. 04/2022