ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 270
Summary
The FDA issued a Class II for ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE by Midlab Incorporated. Reason: cGMP Deviations: Out of specification results for micro in hand soap products..
Details
Source
Drug Recall
External ID
D-0090-2025
Action Date
2024-12-11
Status
Ongoing
Category
drug
Product Description
ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701 Hereford St., St. Louis, MO 63139
Lot/Code Info: Lot 0711241
Reason for Recall
cGMP Deviations: Out of specification results for micro in hand soap products.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-06
Company
Athens, TN
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 64 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Midlab Incorporated has 8 FDA actions in our database, including 8 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 (Midlab Incorporated) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Midlab Incorporated have FDA actions?
Midlab Incorporated has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0090-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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