Drug 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

D-0315-2024

January 10, 2024

Class II

Product summary

Firm: MEDLINE INDUSTRIES, LP - Northfield
Event: Event 93846
Status: Ongoing
Classification: Class II
Quantity: 1,786 tubes
Official record key: drug-enforcement:D-0315-2024

Official wording

Reason: 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.

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

Distribution pattern: Nationwide in the USA

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.