MHRA Class 2 Medicines Recall: Itraconazole 10mg/ml Oral Solution (Kent Pharma UK)

Drug alert number: EL (24)A/26

Date issued: 04 July 2024

Kent Pharma UK is recalling various batches of Itraconazole 10mg/ml Oral Solution as a precautionary measure due to out of specification in the appearance of the solution, particularly the presence of suspended particles or clusters of crystals: Itraconazole 10mg/ml Oral Solution (Kent Pharma UK) PL 51463/0099

SNOMED Code: 26421511000001104

Batch No Expiry Date Pack Size First Distributed
231069 Dec/2024 150ml Oct/2023
231071 Dec/2024 150ml Oct/2023

Active Pharmaceutical Ingredient: Itraconazole

Brief description of the problem

Kent Pharma UK is recalling the above batches of Itraconazole 10mg/ml Oral Solution as a precautionary measure due to out of specification in the appearance of the solution, particularly the presence of suspended particles or clusters of crystals. Initial investigations indicate this is a solubilisation issue of the active ingredient for the above batches. This means that there is the potential for some doses to have lower active ingredient (itraconazole) in solution. The root cause of this issue is under investigation, but based on the potential for underdosage, the impacted batches are being recalled as a precautionary measure.

Advice for healthcare professionals

Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Full drug alert can be viewed here.

Advice for patients

No further action is required by patients as this is a Pharmacy/Wholesaler level recall. 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. If you have any concerns, please speak to a healthcare professional.

Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Further Information

For medical information enquiries please contact medical@kent-athlone.com

For stock control enquiries please contact customer.services@kent-athlone.com

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