Class II · Moderate risk
Fungal Fusion ERADICATION Solution
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Medline Remedy Clinical TREAT Antifungal Cream (Miconazole Nitrate)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ (118 mL) tube, Manufactured for Medline Industries, LP Three Lakes Drive, Northfield, IL 60093. NDC: 53329-147-44
Affected NDC
53329-0147-44
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 |
|---|---|---|---|---|
| Medline miconazole nitrate NDC 53329-0147 |
20 mg/mL | Cream Topical |
Medline Industries, LP | OTC |
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0315-2024 · 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.
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 I · High risk
TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder
Chemical Contamination; presence of benzene.
Class II · Moderate risk
Clinical TREAT Antifungal Powder
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.
Class I · High risk
Lotrimin Af
Chemical Contamination: presence of benzene
Other recalls by MEDLINE INDUSTRIES, LP - Northfield
All 2024 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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