Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ (118...
FDA Recall #D-0315-2024 — Class II — January 10, 2024
Product Description
Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ (118 mL) tube, Manufactured for Medline Industries, LP Three Lakes Drive, Northfield, IL 60093. NDC: 53329-147-44
Reason for Recall
Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.
Recalling Firm
MEDLINE INDUSTRIES, LP - Northfield — Northfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1,786 tubes
Distribution
Nationwide in the USA
Code Information
Lot #s: 08926; 08926A Exp. 8/2025; 08928 Exp. 9/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated