Clinical TREAT Antifungal Powder — Class II drug recall D-0091-2024
Terminated recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2023-11-15, distributed nationwide. CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock wh
| Recall number | D-0091-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2023-10-04 |
| Classified | 2023-11-07 |
| Reported by FDA | 2023-11-15 |
| Terminated | 2024-09-30 |
| Distributed | Nationwide (US) |
| Reason classes | potency, cgmp |
| NDC | 53329-0169, 53329-0169-79 |
| Lot numbers | 007782 |
| Expiration dates | 2024-08-31 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0091-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.