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Kent Pharma UK has announced a precautionary recall of multiple batches of Itraconazole 10mg/ml oral solution following the identification of out-of-specification appearance in the solution, particularly the presence of suspended particles or clusters of crystals. Itraconazole is an antifungal medication prescribed for treating fungal or yeast infections in different parts of the body. Its oral solution form is specifically intended for treating oropharyngeal or esophageal candidiasis, commonly known as thrush or oral thrush. The Medicines and Healthcare products Regulatory Agency (MHRA) has advised the recall following initial investigations, which indicated a solubilisation issue of the active ingredient, itraconazole. This problem may result in some doses containing lower amounts of the active ingredient. The root cause of the issue is currently under investigation. However, due to the potential for underdosage, the affected batches are being recalled as a precautionary measure.

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