Drug & medication recalls High risk

Valisa MFG LLC recalls kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles, Distributed by: Valisa MFG, LLC, Farmi…

Recall date
December 6, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0363-2022
FDA classification
Class I
Brand / firm
Valisa MFG LLC
Sold / distributed
Nationwide in the USA

Why it was recalled

Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What 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

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