Medicines defect noticeMHRA
Blumont Pharma Limited defect notice over a labelling error
Blumont Pharma Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of the batch of Chloramphenicol 1% w/w Eye Ointment (POM version only) in the below table.
Check your product
Only products that match these details are covered. Have your pack in front of you.
3 identifiers listed for this notice.
Blumont Pharma Limited 4g tube
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- C0233
- ExpiryOn the carton, blister or label.
- 03/2029
- First distributedOn the product, its label or its packaging.
- 25.04.2025
What to do now
The issue with Blumont Pharma Limited is information: something on the packaging or leaflet is wrong or missing.
- 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
Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement.
If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (EL(25)A/20). Quoted as issued.
Summary
Blumont Pharma Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of the batch of Chloramphenicol 1% w/w Eye Ointment (POM version only) in the below table.
The risk
DMRC reference number DMRC-35465724 Marketing Authorisation Holder
Advice for healthcare professionals
Healthcare professionals and recipients of this notification are advised not to use these batches of medicine in robotic or automated dispensing or stocking systems and to carry out manual dispensing and stocking, as appropriate.
Blumont Pharma Limited have confirmed that the defect is limited to the one batch of product in the above table.
Product quality of the Chloramphenicol 1% w/w Eye Ointment (POM) is not impacted by this issue; the barcode on the defective packs will identify Chloramphenicol 0.5% eye drops 10ml (POM), having the same active ingredient, same indication (Bacterial conjunctivitis) and the same duration of use, therefore the affected batches are not being recalled.
No action is needed from patients, continue to take this medication as prescribed. The issue is related to the wrong barcode on the cartons of the listed batch of Chloramphenicol 1% w/w Eye Ointment (POM) and will be controlled by the healthcare professional’s prescribing/dispensing the medication. The quality of the medication is not affected.
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 needed from patients, continue to take this medication as prescribed. The issue is related to the wrong barcode on the cartons of the listed batch of Chloramphenicol 1% w/w Eye Ointment (POM) and will be controlled by the healthcare professional’s prescribing/dispensing the medication. The quality of the medication is not affected.
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 Blumont Pharma Limited been recalled?
The issue with Blumont Pharma Limited is information: something on the packaging or leaflet is wrong or missing. 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?
Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement. If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.