D-0315-2024Class II

MEDLINE INDUSTRIES, LP - Northfield

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2024-02-14

Distribution

Nationwide in the USA

Firm state

Product quantity

1,786 tubes

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Documentation & Change Control

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.

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

Code / lot info

Lot #s: 08926; 08926A Exp. 8/2025; 08928 Exp. 9/2025

Other recalls SPEQ maps to Documentation & Change Control

2026-07-22Class IIDaavlin Distributing Company 2026-07-22Class ID'Dioses Fruit Pops, Inc.2026-07-22Class ID'Dioses Fruit Pops, Inc.2026-07-22Class IIChocolate Bar Holdings LLC

See all Documentation & Change Control recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.