kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles, Distributed by: ...
FDA Recall #D-0363-2022 — Class I — December 6, 2021
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
Recalling Firm
Valisa MFG LLC — Farmingdale, NY
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
7704 bottles
Distribution
Nationwide in the USA
Code Information
Lot #: 1260-1, 1260-2, 1260-3, 1260-4. Exp. 04/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated