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

FDA recall notice · announced November 15, 2023 · Medline Industries, Lp - Northfield

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

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.

Notes

Distribution: Nationwide
Lot/code information: Lot 007782, Exp 08/31/2024
Status: Terminated
Products in this recall event:
- 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 (D-0091-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.