Class II
Terminated
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
This recall has been terminated (originally issued November 15, 2023).
- Recall Initiated
- October 4, 2023
- Posted
- November 15, 2023
- Recall Number
- D-0091-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Northfield, IL, United States
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide
Lot / Code Info
Lot 007782, Exp 08/31/2024
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