D-0315-2024 Class II Ongoing
FDA drug recall D-0315-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Jan 10, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 1,786 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 14, 2024
- Initiation Date
- Jan 10, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,786 tubes
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #s: 08926; 08926A Exp. 8/2025; 08928 Exp. 9/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0315-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026