artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz (236 ml) bottles, Dist. By artnatur
Summary
The FDA issued a Class II for artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 f by VIRGIN SCENT INC. Reason: CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot.
Details
Source
Drug Recall
External ID
D-0783-2022
Action Date
2022-04-27
Status
Terminated
Category
drug
Product Description
artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz (236 ml) bottles, Dist. By artnaturals, Gardena, CA 90248, UPC: 8 16820 02820 5
Lot/Code Info: Lot: G20109D, G2019E, G20125E, G20125F, G20125D, G20125A, G20126C, G20126A, G20126D, G20126B, G20126E, G20127C, G20127B, G20127D, G20127A, G20127F, G20127A, G20128B, G20128C, G20128D, G20128E, G20128F, G20129B, G20129A, G20129C, G20129D, G20129E, G20130B, G20130A, G20130C, G20132A, G20132B, G20133A, EXP 5/1/2022; G20133A, EXP 8/1/2022
Quantity Affected: 570,268 Bottles
Reason for Recall
CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot
Distribution
Nationwide in the U.S.A
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-26
Company
Gardena, 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 31 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
VIRGIN SCENT INC has 3 FDA actions in our database, including 3 recalls.
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 (VIRGIN SCENT INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does VIRGIN SCENT INC have FDA actions?
VIRGIN SCENT INC has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0783-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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