Medicines recallMHRA
Class 4 Medicines Notification, Chemidex Pharma Ltd, Various Products recalled over a labelling error
Chemidex Pharma Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in their topical steroid products does not contain all the required safety information. Cartons for the products/batches listed are missing side effect information related to Visual Disturbances.
Check your product
Only products that match these details are covered. Have your pack in front of you.
5 identifiers listed for this notice.
Class 4 Medicines Notification, Chemidex Pharma Ltd, Various Products
- Product licenceThe PL number on the carton.
- PL17736/0130
- PL17736/0127
- PL17736/0268
- PL17736/0100
- PL17736/0101
What to do now
A printing or labelling mistake affects some packs of Class 4 Medicines Notification, Chemidex Pharma Ltd, Various Products.
- 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 (EL(25)A/21). Quoted as issued.
Summary
Chemidex Pharma Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in their topical steroid products does not contain all the required safety information. Cartons for the products/batches listed are missing side effect information related to Visual Disturbances.
The risk
DMRC reference number DMRC-35334505 Marketing Authorisation Holder
Advice for healthcare professionals
Healthcare professionals are advised to review the information contained within this notification and take this into account when prescribing these products
When product from batches included in the tables are supplied or dispensed, please ensure that patients are aware of the missing information.
The missing information is:
PIL Section 2
Contact your doctor if you experience blurred vision or other visual disturbances.
PIL Section 4
Side effects where the frequency is not known:
Blurred vision.
Patients should continue to take medicines from the impacted batches as prescribed by your healthcare professional. The quality of the impacted batches is not affected which is why the products are not being recalled.
There is some missing information in the patient leaflet which is presented below:
Section 2
Contact your doctor if you experience blurred vision or other visual disturbances.
Advice for patients
Patients should continue to take medicines from the impacted batches as prescribed by your healthcare professional. The quality of the impacted batches is not affected which is why the products are not being recalled.
There is some missing information in the patient leaflet which is presented below:
Section 2
Contact your doctor if you experience blurred vision or other visual disturbances.
Section 4
Side effects where the frequency is not known:
Blurred vision.
If you have any concerns about the information provided with your medicine, please speak with your pharmacy team in the first instance. 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, Chemidex Pharma Ltd, Various Products been recalled?
A printing or labelling mistake affects some packs of Class 4 Medicines Notification, Chemidex Pharma Ltd, Various Products. 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 product licence 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.