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 reference number
DMRC-31353215
Company name
Star Pharmaceuticals Limited
Diflucan Oral Suspension 40mg/ml, PLPI 20636/3070
SNOMED Code
N/A
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| B861104 | 09/2026 | 35 ml | 20/05/2024 |
| B694104 | 12/2024 | 35 ml | 11/06/2024 |
Active Pharmaceutical Ingredient: fluconazole
Brief description of the 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 for 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 for 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.
Further Information
For medical information enquiries please contact the distributor, Drugsrus Limited on 0208 423 3800, [email protected].
For stock control enquiries please contact the distributor, Drugsrus Limited on 0208 423 3800, [email protected].
Recipients of this Medicines Notification 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
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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