Medicines recallMHRA
Class 4 Medicines Notification, Star Pharmaceuticals Limited recalled over a labelling error
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.
Check your product
Only products that match these details are covered. Have your pack in front of you.
6 identifiers listed for this notice.
Class 4 Medicines Notification, Star Pharmaceuticals Limited 35 ml
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- B861104
- B694104
- ExpiryOn the carton, blister or label.
- 09/2026
- 12/2024
- First distributedOn the product, its label or its packaging.
- 20/05/2024
- 11/06/2024
What to do now
A printing or labelling mistake affects some packs of Class 4 Medicines Notification, Star Pharmaceuticals Limited.
- Keep taking your medicine unless a healthcare professional tells you otherwise.
- Check the batch number and expiry date on your pack against the list on this page.
- If it matches, your pharmacist can swap it or arrange an alternative.
- Report suspected side effects to the MHRA Yellow Card scheme.
Why it matters. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.
Symptoms and when to get help
Look out for
- a side effect you have not had before
- your condition not being controlled as well as usual
Get help urgently
- signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
- if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111
This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.
Replacements and prescriptions
The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping.
An affected pack bought over the counter can be returned to where you bought it.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (class-4-medicines-notification-star-pharmaceuticals-limited-). Quoted as issued.
Summary
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.
The risk
DMRC reference number DMRC-31353215 Company name
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.
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 .
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 .
Open the MHRA notice
Questions
Why has Class 4 Medicines Notification, Star Pharmaceuticals Limited been recalled?
A printing or labelling mistake affects some packs of Class 4 Medicines Notification, Star Pharmaceuticals Limited. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.
How do I know if my medicine is affected?
Compare the batch code, expiry and date code on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.
What should I do now?
Keep taking your medicine unless a healthcare professional tells you otherwise. Check the batch number and expiry date on your pack against the list on this page.
Do I need a new prescription?
The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping. An affected pack bought over the counter can be returned to where you bought it.