Medicines defect noticeMHRA
Ocumont Eye Ointment 1% w/w defect notice over a labelling error
Blumont Pharma Limited is reporting to the MHRA regarding the absence of Braille on the outer carton of one batch of Ocumont Eye Ointment 1% w/w (POM). It was identified that the Braille information was inadvertently omitted during the approval and release process.
Check your product
Only products that match these details are covered. Have your pack in front of you.
3 identifiers listed for this notice.
Ocumont Eye Ointment 1% w/w 1
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- B0866
- ExpiryOn the carton, blister or label.
- 30/11/2028
- First distributedOn the product, its label or its packaging.
- 10/03/2025
What to do now
There is an error on the label, carton or patient leaflet for Ocumont Eye Ointment 1% w/w.
- Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect.
- Compare the batch number printed on the box or label with the batches listed here.
- If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
- Any side effect you think is linked can be reported through the 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
If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself.
Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (EL(26)A/03). Quoted as issued.
Summary
Blumont Pharma Limited is reporting to the MHRA regarding the absence of Braille on the outer carton of one batch of Ocumont Eye Ointment 1% w/w (POM). It was identified that the Braille information was inadvertently omitted during the approval and release process.
The risk
DMRC reference number DMRC-38025137 Marketing Authorisation Holder
Advice for healthcare professionals
Healthcare professionals are advised to be aware that the outer carton of the affected batch does not contain Braille. Appropriate support should be provided to patients with visual impairment when dispensing this product, in line with local procedures.
The quality of the ointment is not impacted by this defect, therefore, the affected batch is not being recalled. All other batches of the product contain Braille on the outer carton.
No action is required from patients. This issue relates to the absence of Braille on the outer carton of a single batch of Ocumont Eye Ointment 1% w/w. The quality of the ointment is not impacted by this defect, therefore, the affected batch is not being recalled. Healthcare professionals will provide appropriate support at the time of dispensing, where required.
Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .
Advice for patients
No action is required from patients. This issue relates to the absence of Braille on the outer carton of a single batch of Ocumont Eye Ointment 1% w/w. The quality of the ointment is not impacted by this defect, therefore, the affected batch is not being recalled. Healthcare professionals will provide appropriate support at the time of dispensing, where required.
Patients who experience adverse reactions or have any questions about their 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 Ocumont Eye Ointment 1% w/w been recalled?
There is an error on the label, carton or patient leaflet for Ocumont Eye Ointment 1% w/w. 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?
Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect. Compare the batch number printed on the box or label with the batches listed here.
Do I need a new prescription?
If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself. Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.