Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industrie
Summary
The FDA issued a Class II for Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bo by Consumer Product Partners, LLC. Reason: Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol.
Details
Source
Drug Recall
External ID
D-0458-2025
Action Date
2025-06-11
Status
Ongoing
Category
drug
Product Description
Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60693 USA. NDC: 53329-202-08, UPC 8 88277 34945 5
Lot/Code Info: Lot, expiry: Lot 0644682, exp 2026/11/14; Lot 0644683, exp 2026/11/16
Quantity Affected: 125,040 bottles
Reason for Recall
Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-23
Company
Smyrna, 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 44 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Consumer Product Partners, LLC has 5 FDA actions in our database, including 5 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 (Consumer Product Partners, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Consumer Product Partners, LLC have FDA actions?
Consumer Product Partners, LLC has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0458-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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