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Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufacture...

FDA Recall #D-0458-2025 — Class II — May 23, 2025

Recall #D-0458-2025 Date: May 23, 2025 Classification: Class II Status: Ongoing

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

Recalling Firm

Consumer Product Partners, LLC — Smyrna, TN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

125,040 bottles

Distribution

Nationwide in the USA.

Code Information

Lot, expiry: Lot 0644682, exp 2026/11/14; Lot 0644683, exp 2026/11/16

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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