GovWire

MDR number

MDR 098-04/24

Company name

Kent Pharma UK

Itraconazole 10mg/ml Oral Solution

PL 51463/0099

SNOMED Code

26421511000001104

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 suppliers approved process.

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 theMHRA 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

Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

Download document

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