FDA Drug recall D-0091-2024
Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal, Manufactured…
- FDA Drug
- Class II
- terminated
- Published 2023-11-15
On 2023-11-15 the FDA classified a Class II recall of Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal, Manufactured… by Medline Industries Northfield, citing 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 act….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0091-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-10-04 |
| Published | 2023-11-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
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
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.
Identifiers
| ndc | 53329-169-79 |
|---|---|
| code_info | Lot 007782, Exp 08/31/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0091-2024%22
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