Recalls / Class II
Class IID-0091-2024
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
- Brand name
- Remedy Antifungal
- Generic name
- Miconazole Nitrate
- Active ingredient
- Miconazole Nitrate
- Route
- Topical
- NDC
- 53329-169
- FDA application
- M005
- Affected lot / code info
- Lot 007782, Exp 08/31/2024
Why it was recalled
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.
Recalling firm
- Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Manufacturer
- Medline Industries, LP
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Lakes Dr, Northfield, Illinois 60093-2753
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2023-10-04
- FDA classified
- 2023-11-07
- Posted by FDA
- 2023-11-15
- Terminated
- 2024-09-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0091-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.