Class 4 Medicines Notification, Star Pharmaceuticals Limited, Diflucan Oral Suspension 40mg/ml, EL(24)A36

Star Pharmaceuticals Limited has informed the MHRA that an error has been identified in the Patient Information Leaflet (PIL) for two batches of Diflucan Oral Suspension 40mg/ml.

DMRC Number: DMRC-31353215

Company name: Star Pharmaceuticals Limited

Product description: Diflucan Oral Suspension 40mg/ml, PLPI 20636/3070

Details of the affected batches: 

Brief description of problem:

Star Pharmaceuticals Limited has informed the MHRA that an error has been identified in the Patient Information Leaflet (PIL) for two batches of Diflucan Oral Suspension 40mg/ml.

Section 6 of the PIL states “50mg of fluconazole per 5ml” instead of “200mg of fluconazole per 5ml”. The other sections of the PIL and product information state the correct strength of 200mg of fluconazole per 5ml.

Advice to Healthcare Professionals:

There is no risk to product quality because of this issue, therefore the affected batch is not being recalled. Healthcare professionals should continue to use the product as normal but be aware of the typographical error highlighted in this notification. Star Pharmaceuticals Limited have also confirmed that they have identified all customers who have been supplied with this product and will initiate direct contact with the relevant customers.

Advice to Patients:

No further action is required by patients. If you have received or receive the impacted batches of Diflucan Oral Suspension 40mg/ml listed in this notification, please continue to take your medicine as prescribed by your doctor and as per the dispensing label. If you have concerns about a medicine you may be using, please contact your 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 the distributor, Drugsrus Limited on 0208 423 3800, info@drugsrus.co.uk.

For stock control enquiries please contact the distributor, Drugsrus Limited on 0208 423 3800, info@drugsrus.co.uk.

To access the full recall: Class 4 Medicines Notification, Star Pharmaceuticals Limited, Diflucan Oral Suspension 40mg/ml, EL(24)A36