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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot 007782, Exp 08/31/2024
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0091-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 4, 2023
- FDA report date
- Nov 15, 2023
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
Original FDA data
Every field from FDA enforcement report D-0091-2024, exactly as published.
Show all FDA fields
- City
- Northfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 93227
- Address
- 3 Lakes Dr
- Code information
- Lot 007782, Exp 08/31/2024
- Postal code
- 60093-2753
- Report date
- Nov 15, 2023
- Product type
- Drugs
- Recall number
- D-0091-2024
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Termination date
- Sep 30, 2024
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 4, 2023
- Initial firm notification
- Letter
- Center classification date
- Nov 7, 2023