D-0458-2025 Class II Ongoing
FDA drug recall D-0458-2025 was initiated by Consumer Product Partners, LLC on May 23, 2025 and is designated Class II. Reason for recall: Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol The recall status is ongoing. Affected quantity: 125,040 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 11, 2025
- Initiation Date
- May 23, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 125,040 bottles
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
Reason for Recall
Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
Distribution Pattern
Nationwide in the USA.
Code Information
Lot, expiry: Lot 0644682, exp 2026/11/14; Lot 0644683, exp 2026/11/16