Class II · Moderate risk
Fungal Fusion ERADICATION Solution
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Clinical TREAT Antifungal Powder (Miconazole Nitrate)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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
Affected NDC
53329-0169-79
Compare with the code on your package — it is the most precise check available.
Drug: Miconazole
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Remedy Antifungal Miconazole Nitrate NDC 53329-0169 |
2 g/100g | Powder Topical |
Medline Industries, LP | OTC |
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0091-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Miconazole recalls
See all
Class II · Moderate risk
DermaFungal
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II · Moderate risk
Medline Remedy Clinical TREAT Antifungal Cream
Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.
Class I · High risk
TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder
Chemical Contamination; presence of benzene.
Class I · High risk
Lotrimin Af
Chemical Contamination: presence of benzene
Other recalls by MEDLINE INDUSTRIES, LP - Northfield
All 2023 recalls
Class II · Moderate risk
Rite Aid Pharmacy
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk
Good Neighbor Pharmacy
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk
H-E-B
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk
ReliOn
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
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