Padagis US LLC is recalling 10,512 cartons of Gynazole-1 (butoconazole nitrate) Vaginal Cream USP, 2%, because the product was manufactured with the wrong type of silica. The manufacturing process used hydrophilic colloidal silica instead of the required hydrophobic colloidal silica. This recall involves single-dose pre-filled applicators sold in individual cartons with lot number 164185 and an expiration date of April 2024.
The use of an incorrect ingredient formulation may affect the physical properties or stability of the cream. This could potentially reduce the effectiveness of the medication in treating vaginal yeast infections.
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Manufactured by Padagis in Yeruham, Israel; Recall number D-0081-2024.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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