Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Reason Chemical Contamination; presence of benzene.
Reason CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation…
Reason Chemical Contamination: presence of benzene
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