Medicines recallMHRA
Class 4 Medicines Notification, Accord Healthcare Limited recalled over a packaging defect
Accord Healthcare Ltd, UK has informed the MHRA about an error with the Patient Information Leaflets (PILs) that have been packaged in the batches of these products mentioned in this notification.
Check your product
Only products that match these details are covered. Have your pack in front of you.
13 identifiers listed for this notice.
Class 4 Medicines Notification, Accord Healthcare Limited 2X14T
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- M2213437
- M2213708
- M2213819
- M2303226
- M2203689
- ExpiryOn the carton, blister or label.
- 08/2025
- 04/2026
- 02/2025
- First distributedOn the product, its label or its packaging.
- 28/06/2023
- 09/05/2023
- 31/03/2023
- 16/05/2023
- 31/01/2023
What to do now
A fault with the packaging or delivery device of Class 4 Medicines Notification, Accord Healthcare Limited has been found.
- 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. A faulty cap, seal, syringe or inhaler can mean a missed or wrong dose, or contamination of the product.
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(23)A/29). Quoted as issued.
Summary
Accord Healthcare Ltd, UK has informed the MHRA about an error with the Patient Information Leaflets (PILs) that have been packaged in the batches of these products mentioned in this notification.
The risk
MDR number 103-08/23 Company name
Advice for healthcare professionals
There is no risk to product quality as a result of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the product and where possible, provide an updated PIL. The updated PIL is available electronically and can be downloaded from the Accord website.
If it is not possible to provide an updated PIL please advise patients of the missing information and the need to seek medical advice if these signs or symptoms occur.
This issue is about missing information on the Patient Information Leaflets (PILs) in specific batches of Olmesartan Medoxomil tables for high blood pressure. The medicine itself is not affected and therefore patients do not need to take any action.
There have been some reports of liver problems in patients taking this medicine, but these do not happen to all patients. If you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started therapy with Olmesartan Medoxomil a long time ago, contact your doctor immediately.
These products will have been prescribed and dispensed by the qualified healthcare professional(s) responsible for your care. Patients should continue to take medicines from these batches as prescribed by your healthcare professional. If you have any concerns, please speak with your pharmacy team in the first instance.
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
This issue is about missing information on the Patient Information Leaflets (PILs) in specific batches of Olmesartan Medoxomil tables for high blood pressure. The medicine itself is not affected and therefore patients do not need to take any action.
There have been some reports of liver problems in patients taking this medicine, but these do not happen to all patients. If you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started therapy with Olmesartan Medoxomil a long time ago, contact your doctor immediately.
These products will have been prescribed and dispensed by the qualified healthcare professional(s) responsible for your care. Patients should continue to take medicines from these batches as prescribed by your healthcare professional. If you have any concerns, please speak with your pharmacy team in the first instance.
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, Accord Healthcare Limited been recalled?
A fault with the packaging or delivery device of Class 4 Medicines Notification, Accord Healthcare Limited has been found. A faulty cap, seal, syringe or inhaler can mean a missed or wrong dose, or contamination of the product.
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.