January 2024 FDA Recall Medline by Medline Industries, Lp - Northfield
D-0315-2024 - Labeling

This Class II drug recall was voluntarily initiated by Medline Industries, Lp - Northfield on January 10, 2024 for the product Medline. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0315-2024

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.
Initiated
01-10-2024
Reported
02-14-2024
Quantity
1,786 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93846
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
MEDLINE INDUSTRIES, LP - Northfield
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

53329-147-44 Medline