Kent Pharma recalls Itraconazole oral solution due to solubilisation issue

Community pharmacists and dispensing GPs are advised to stop supplying the affected batches of the Itraconazole 10mg/ml oral solution immediately

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.

The impacted batches are:

Community pharmacists and dispensing general practitioners are advised to stop supplying the affected batches immediately.

“Quarantine all remaining stock and return it to your supplier using your supplier’s approved process,” the MHRA has advised healthcare professionals.

Since this recall is at the pharmacy/wholesaler level, no action is needed from patients, the agency noted.

Patients are assured that the issue poses no direct harm and is unlikely to affect the effectiveness of their treatment.

The medicines recall notice issued by the MHRA reads: “The impacted batches may exhibit suspended particles or clusters of crystals, which present no direct harm, however, it may mean that some doses have lower active ingredient (itraconazole) in solution.

“This is unlikely to impact the effectiveness of your treatment and the recall is a precautionary measure.

Patients are encouraged to speak to a healthcare professional if they have any concerns, seek medical attention if they experience adverse reactions and report via the MHRA Yellow Card scheme.

NHS regional teams are asked to forward this medicine recall to community pharmacists and dispensing general practitioners for information.