Cleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chloride 0.1%, New Wave Cleaning Solutions LLC
Summary
The FDA issued a Class II for Cleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chlori by Sanitor Corporation. Reason: CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or soft tissues..
Details
Source
Drug Recall
External ID
D-0018-2022
Action Date
2021-10-27
Status
Terminated
Category
drug
Product Description
Cleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chloride 0.1%, New Wave Cleaning Solutions LLC, 7001 W Arby Ave Suite 100, Las Vegas, NV 89113, UPC#: 8 60001 93396 3
Lot/Code Info: Lot # 20102, 20103, Exp, Sept, 2021;
Quantity Affected: unknown
Reason for Recall
CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or soft tissues.
Distribution
Distributed to one distributor located in Las Vegas, NV.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-21
Company
Stanton, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 32 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (Sanitor Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sanitor Corporation have FDA actions?
This is the only FDA action we have on record for Sanitor Corporation in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0018-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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