Medicines defect noticeMHRA
Pantoprazole 40 mg Gastro-Resistant Tablets defect notice over a labelling error
Crescent Pharma Limited has informed the MHRA regarding an error with the European Article Number (EAN) barcode on the cartons of the above-mentioned batches of Pantoprazole 40 mg Gastro-Resistant Tablets distributed by Crescent Pharma Limited.
Check your product
Only products that match these details are covered. Have your pack in front of you.
18 identifiers listed for this notice.
Pantoprazole 40 mg Gastro-Resistant Tablets 28
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- ET571E3001
- ET571E3002
- ET571E3003
- ET571E3004
- ET571E3005
- ET571E3006
- ET571E3007
- ET571E3008
- Product licenceThe PL number on the carton.
- PL 45841/0018
- ExpiryOn the carton, blister or label.
- May 2025
- Jun 2025
- First distributedOn the product, its label or its packaging.
- 18/10/2023
- 26/09/2023
- 13/09/2023
- 20/11/2023
- 17/01/2024
- 19/12/2023
- Not yet distributed
What to do now
A printing or labelling mistake affects some packs of Pantoprazole 40 mg Gastro-Resistant Tablets.
- 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(24)A/03). Quoted as issued.
Summary
Crescent Pharma Limited has informed the MHRA regarding an error with the European Article Number (EAN) barcode on the cartons of the above-mentioned batches of Pantoprazole 40 mg Gastro-Resistant Tablets distributed by Crescent Pharma Limited.
The risk
MDR number MDR 098-01/24 Company name
Advice for healthcare professionals
Product quality of the Pantoprazole 40 mg Gastro-Resistant Tablets is not impacted by this issue, therefore the affected batches are not being recalled. 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.
The manufacturer has confirmed that the batch that has yet to be distributed will be accompanied by a note explaining the issue to supplement dispensing at pharmacies. These batches will not be repackaged to avoid any supply concerns.
Cadila Pharmaceuticals (UK) Limited and Crescent Pharma Limited have confirmed that all future batches of the product will have the correct EAN barcode.
No action is needed from patients. The issue is related to the wrong barcode on the cartons of the listed batches of Pantoprazole 40 mg Gastro-Resistant Tablets and will be controlled by the healthcare professional dispensing the medication. The quality of the medication itself is not affected.
Patients should continue to take medicines from these batches as prescribed by 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.
Advice for patients
No action is needed from patients. The issue is related to the wrong barcode on the cartons of the listed batches of Pantoprazole 40 mg Gastro-Resistant Tablets and will be controlled by the healthcare professional dispensing the medication. The quality of the medication itself is not affected.
Patients should continue to take medicines from these batches as prescribed by 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 Pantoprazole 40 mg Gastro-Resistant Tablets been recalled?
A printing or labelling mistake affects some packs of Pantoprazole 40 mg Gastro-Resistant Tablets. 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?
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.