FDAFDA · Food and drugs·Recall number D-0091-2024
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
Published November 15, 2023 · Recall initiated: October 4, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- REMEDY ANTIFUNGAL
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Nationwide
- UPC
- 0080196528564
- Lot
- Lot 007782, Exp 08/31/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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