MEDLINE INDUSTRIES, LP - Northfield: Drug Recall

Recall #D-0091-2024 · 10/04/2023

Class II: Risk

Recall Details

Recall Number
D-0091-2024
Classification
Class II
Product Type
Drug
Recalling Firm
MEDLINE INDUSTRIES, LP - Northfield
Status
Terminated
Date Initiated
10/04/2023
Location
Northfield, IL, United States
Voluntary/Mandated
Voluntary: Firm initiated

Reason for Recall

CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate.

Product Description

Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, NDC: 53329-169-79

Distribution Pattern

Nationwide

Other Recalls by MEDLINE INDUSTRIES, LP - Northfield

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.