PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: January 5, 2022 Initiated: December 6, 2021 #D-0363-2022

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

Details

Recalling Firm
Valisa MFG LLC
Units Affected
7704 bottles
Distribution
Nationwide in the USA
Location
Farmingdale, NY

Frequently Asked Questions

What product was recalled?
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. Recalled by Valisa MFG LLC. Units affected: 7704 bottles.
Why was this product recalled?
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Which agency issued this recall?
This recall was issued by the FDA Drug on January 5, 2022. Severity: Critical. Recall number: D-0363-2022.