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Recall Observatory FDA recall evidence

Drug product

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

D-0091-2024

October 04, 2023

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 93227
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-0091-2024

Official wording

Reason: 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.

Code information: Lot 007782, Exp 08/31/2024

Distribution pattern: Nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP deviations