Class IIOngoing

Medline Remedy Clinical TREAT Antifungal Cream recall

FDA recall D-0315-2024 · initiated Jan 10, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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.

Details

Product: 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
Recalling company: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Initiated: Jan 10, 2024
FDA report date: Feb 14, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0315-2024 ↗

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