Drug Enforcement D-0315-2024

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.

Status

Ongoing

Classification

Class II

Report Date

February 14, 2024

Termination Date

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Product Information

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
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.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Address
3 Lakes Dr

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0315-2024
Event ID
93846
Recall initiation date
January 10, 2024
Center classification date
February 6, 2024
Code info
Lot #s: 08926; 08926A Exp. 8/2025; 08928 Exp. 9/2025
More code info
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