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.
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
Lot numbers, UPCs & expiration codes
Lot #s: 08926; 08926A Exp. 8/2025; 08928 Exp. 9/2025
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0315-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jan 10, 2024
- FDA report date
- Feb 14, 2024
- Quantity
- 1,786 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
Original FDA data
Every field from FDA enforcement report D-0315-2024, exactly as published.
Show all FDA fields
- City
- Northfield
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 93846
- Address
- 3 Lakes Dr
- Code information
- Lot #s: 08926; 08926A Exp. 8/2025; 08928 Exp. 9/2025
- Postal code
- 60093-2753
- Report date
- Feb 14, 2024
- Product type
- Drugs
- Recall number
- D-0315-2024
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jan 10, 2024
- Initial firm notification
- Letter
- Center classification date
- Feb 6, 2024