D-0091-2024 Class II Terminated
FDA drug recall D-0091-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on October 4, 2023 and is designated Class II. 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 micona… The recall status is terminated (terminated September 30, 2024).
Recall Details
- Product Type
- Drugs
- Report Date
- November 15, 2023
- Initiation Date
- October 4, 2023
- Termination Date
- September 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
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
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.
Distribution Pattern
Nationwide
Code Information
Lot 007782, Exp 08/31/2024