Valisa MFG LLC: Drug Recall

Recall #D-0363-2022 · 12/06/2021

Class I: Dangerous

Recall Details

Recall Number
D-0363-2022
Classification
Class I
Product Type
Drug
Recalling Firm
Valisa MFG LLC
Status
Terminated
Date Initiated
12/06/2021
Location
Farmingdale, NY, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7704 bottles

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.