← FDA ENFORCEMENT
D-0091-2024Class II

MEDLINE INDUSTRIES, LP - Northfield

Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Product type
Drug
Status
Terminated
Report date
2023-11-15
Distribution
Nationwide
Firm state
IL
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
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

Code / lot info

Lot 007782, Exp 08/31/2024

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.