MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alcohol 70% v/v), 10 FL OZ / 300 mL, Manufactur
Summary
The FDA issued a Class II for MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alcohol by Global Sanitizers LLC. Reason: CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot fo.
Details
Source
Drug Recall
External ID
D-0778-2021
Action Date
2021-09-08
Status
Ongoing
Category
drug
Product Description
MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alcohol 70% v/v), 10 FL OZ / 300 mL, Manufactured by Grupo V-Klean S.A. de C.V, Calle Alborada 124, Parques del Pedregal, Tlalpan, 14250 Ciudad de Mexico, CDMX, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC: 6 76753 00417 8
Lot/Code Info: Lot No: GV4420205 Best By, 5/21/2022
Quantity Affected: 50,000 bottles
Reason for Recall
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Distribution
Product Distributed Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-12
Company
Las Vegas, NV
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 40 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Global Sanitizers LLC has 6 FDA actions in our database, including 6 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 (Global Sanitizers LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Global Sanitizers LLC have FDA actions?
Global Sanitizers LLC has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0778-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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