FDA Recall D-0315-2024

MEDLINE INDUSTRIES, LP - Northfield · Northfield, IL

Class II Ongoing 855 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

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

Quantity: 1,786 tubes

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.

Recall record

Recall number: D-0315-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2024-01-10
Classified by FDA Center: 2024-02-06
FDA published: 2024-02-14
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Firm location: Northfield, IL

Drug identification

Brand name(s): MEDLINE
Generic name(s): MICONAZOLE NITRATE
Manufacturer(s): Medline Industries, LP
NDC(s): 53329-147
Route(s): TOPICAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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