Recalls / Class II
Class IID-0315-2024
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
- Brand name
- Medline
- Generic name
- Miconazole Nitrate
- Active ingredient
- Miconazole Nitrate
- Route
- Topical
- NDC
- 53329-147
- FDA application
- M005
- Affected lot / code info
- Lot #s: 08926; 08926A Exp. 8/2025; 08928 Exp. 9/2025
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.
Recalling firm
- Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Manufacturer
- Medline Industries, LP
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Lakes Dr, Northfield, Illinois 60093-2753
Distribution
- Quantity
- 1,786 tubes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-01-10
- FDA classified
- 2024-02-06
- Posted by FDA
- 2024-02-14
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0315-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.