READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured
Summary
The FDA issued a Class III for READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 by Medline Industries, LP. Reason: Subpotent drug.
Details
Source
Drug Recall
External ID
D-0674-2025
Action Date
2025-10-01
Status
Ongoing
Category
drug
Product Description
READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured in USA by Medline Industries, LP., Three Lakes Drive, Northfield, IL 60093, NDC 53329-939-25
Lot/Code Info: Lot # 24EJA180, Exp 06/01/2027
Quantity Affected: 2,680 bottles
Reason for Recall
Subpotent drug
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-19
Company
Northfield, IL
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 70 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 clearances.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0674-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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