18 FDA recalls mention Miconazole. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Miconazole.
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 Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of…
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
Reason Chemical Contamination: presence of benzene
Reason Chemical Contamination: presence of benzene
Reason cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Reason cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Reason cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Reason cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason CGMP Deviations
Reason Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back…
Reason Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include only the 1200 mg vaginal suppository; the approved NDA…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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