Medicines recallMHRA
Class 4 Medicines Notification recalled over a labelling error
Jubilant Pharmaceuticals NV has informed the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed in this notification include an outdated PIL.
Check your product
Only products that match these details are covered. Have your pack in front of you.
37 identifiers listed for this notice.
Class 4 Medicines Notification 28
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- IR222002A
- IR222003A
- IR222004A
- IR222006A
- IR222007A
- IR222008A
- IR224001A
- IR224002A
- IR224003A
- IR224004A
- IR322001C
- IR322002C
- IR322003A
- IR324002A
- IR324003A
- IR324004A
- Product licenceThe PL number on the carton.
- PL 19156/0089
- PL 19156/0090
- ExpiryOn the carton, blister or label.
- 08/2025
- 09/2025
- 03/2027
- 06/2027
- 02/2025
- First distributedOn the product, its label or its packaging.
- 5 December 2023
- 8 January 2024
- 16 November 2023
- 5 February 2024
- 1 March 2024
- 2 April 2024
- 5 September 2024
- 12 September 2024
- 19 September 2024
- 20 November 2024
- 1 February 2024
- 11 November 2024
- 26 November 2024
- 6 December 2024
What to do now
The issue with Class 4 Medicines Notification 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/02). Quoted as issued.
Summary
Jubilant Pharmaceuticals NV has informed the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed in this notification include an outdated PIL.
The risk
DMRC reference number DMRC 34132023 Company name
Advice for healthcare professionals
Healthcare professionals are advised to review the information contained within this notification and take this into account when prescribing this product. When product from batch included in the table is supplied or dispensed, please ensure that patients are aware of the missing information. As the patients would not find current PIL (dated: Aug 2022) in the packs, please inform the patients that this latest (current) PIL of Irbesartan Jubilant film-coated tablets is already available on the MHRA’s website .
Patients should continue to take medicines from the impacted batch as prescribed by your healthcare professional. This does not affect the quality of the product. There are updated safety information in the latest patient information leaflet (PIL) which accompanies the medicine. The latest (current: last revised in Aug 2022) PIL is already available on the MHRA’s website .
As per current PIL there is some missing information which is presented below:
What you need to know before you take Irbesartan Jubilant
Warnings and precautions
Talk to your doctor or pharmacist before taking Irbesartan Jubilant if
if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heart beat), particularly if you are being treated for diabetes.
You may need to have blood checks if you take:
repaglinide (medication used for lowering blood sugar levels)
Possible side effects
Decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, severe allergic reactions (anaphylactic shock) and low blood sugar levels.
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
Patients should continue to take medicines from the impacted batch as prescribed by your healthcare professional. This does not affect the quality of the product. There are updated safety information in the latest patient information leaflet (PIL) which accompanies the medicine. The latest (current: last revised in Aug 2022) PIL is already available on the MHRA’s website .
As per current PIL there is some missing information which is presented below:
What you need to know before you take Irbesartan Jubilant
Warnings and precautions
Talk to your doctor or pharmacist before taking Irbesartan Jubilant if
if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heart beat), particularly if you are being treated for diabetes.
You may need to have blood checks if you take:
repaglinide (medication used for lowering blood sugar levels)
Possible side effects
Decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, severe allergic reactions (anaphylactic shock) and low blood sugar levels.
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 been recalled?
The issue with Class 4 Medicines Notification 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, product licence, 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.