Class 2 Medicines Recall: Kent Pharma UK, Itraconazole 10mg/ml Oral Solution, EL(24)A/26

Class 2 Medicines Recall: Kent Pharma UK, Itraconazole 10mg/ml Oral Solution, EL(24)A/26

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.

MDR Number: MDR 098-04/24

Company name: Kent Pharma UK

Product description: Itraconazole 10mg/ml Oral Solution PL 51463/0099

SNOMED Code: 26421511000001104

Details of the affected batch: 

Active Pharmaceutical Ingredient: Itraconazole

Brief description of 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 to Healthcare Professionals:

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

Advice to 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.

Company contacts for further information:

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

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

To access the full recall: 

Class 2 Medicines Recall: Kent Pharma UK, Itraconazole 10mg/ml Oral Solution, EL(24)A/26