HAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic 80% Topical Non-Sterile Solution, 12 FL OZ (254 mL) bottles, Dist
Summary
The FDA issued a Class II for HAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic 80% Topical Non-Sterile S by Hand Sanitizer LLC. Reason: CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits..
Details
Source
Drug Recall
External ID
D-1149-2022
Action Date
2022-06-22
Status
Terminated
Category
drug
Product Description
HAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic 80% Topical Non-Sterile Solution, 12 FL OZ (254 mL) bottles, Distributed by: Hand Cleansing Gel 850 Kaliste Saloom Rd. Suite 212 Lafayette, LA 70508 UPC 8 60003 62626 9
Lot/Code Info: Batch# 100620-128201, 100620-128202, 100620-128203, 100620-128204, 100620-128205, 100620-128206, 100620-128207, 100620-128208, 100620-128209, 100620-128210, 100620-128211, 100620-128212
Quantity Affected: 24,020 bottles
Reason for Recall
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Distribution
Firm failed to provide distribution pattern information.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-04
Company
Lafayette, LA
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 176 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 (Hand Sanitizer LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hand Sanitizer LLC have FDA actions?
This is the only FDA action we have on record for Hand Sanitizer LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1149-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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