kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles, Distributed by: Valisa MFG, LLC, Farmin
Summary
The FDA issued a Class I for kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles, by Valisa MFG LLC. Reason: Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol.
Details
Source
Drug Recall
External ID
D-0363-2022
Action Date
2022-01-05
Status
Terminated
Category
drug
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
Lot/Code Info: Lot #: 1260-1, 1260-2, 1260-3, 1260-4. Exp. 04/2022
Quantity Affected: 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
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-06
Company
Farmingdale, NY
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 51 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Valisa MFG LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Valisa MFG LLC have FDA actions?
This is the only FDA action we have on record for Valisa MFG LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0363-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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