Drug Enforcement D-0091-2024

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.

Status

Terminated

Classification

Class II

Report Date

November 15, 2023

Termination Date

September 30, 2024

Product Information

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
Product quantity
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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.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide

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-0091-2024
Event ID
93227
Recall initiation date
October 4, 2023
Center classification date
November 7, 2023
Code info
Lot 007782, Exp 08/31/2024
More code info
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