Medicines recallMHRA
Class 4 Medicines Notification recalled over a labelling error
Bristol Laboratories Limited has informed the MHRA that the Patient Information Leaflet (PIL) in the batches in the table for Rabeprazole sodium 10mg and 20mg gastro-resistant tablets do not contain the most up to date safety information.
Check your product
Only products that match these details are covered. Have your pack in front of you.
18 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.
- LC72047
- LC74744
- LC76888
- LC72045
- LC75526
- LC76906
- Product licenceThe PL number on the carton.
- PLGB 17907/0457
- PLGB 17907/0458
- ExpiryOn the carton, blister or label.
- 10/2025
- 02/2026
- 05/2026
- 12/2025
- 08/2026
- First distributedOn the product, its label or its packaging.
- 4 September 2023
- 18 October 2023
- 30 September 2024
- 8 March 2023
- 24 August 2023
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/01). Quoted as issued.
Summary
Bristol Laboratories Limited has informed the MHRA that the Patient Information Leaflet (PIL) in the batches in the table for Rabeprazole sodium 10mg and 20mg gastro-resistant tablets do not contain the most up to date safety information.
The risk
DMRC reference number DMRC 33946703 Company name
Advice for healthcare professionals
The quality of medicine has not been affected, therefore, the affected batches are not being recalled.
Healthcare professionals are advised to ensure that the patients are aware of the updated safety information when dispensing the affected batches of product. Please provide a copy of the updated PIL and remind the patient to read the entire leaflet before taking the medicine. The electronic version of the PIL is up to date and can be accessed via the following links:
Rabeprazole sodium 10mg gastro-resistant tablets
Rabeprazole sodium 20mg gastro-resistant Tablets
The quality of medicine has not been affected, therefore patients do not need to take any action. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.
Patients should be aware that the Patient Information Leaflet (PIL) included in the packs of the above specified batches of medicines does not contain the most up to date safety information. The affected sections of the PIL are included in the table under ‘Brief description of the problem’. The up-to-date version of the Patient Information Leaflet can be accessed via the links below. Please read this before taking the medicine.
Rabeprazole sodium 10mg gastro-resistant tablets
Rabeprazole sodium 20mg gastro-resistant Tablets
If you have any concerns about the information provided with your medicine, please speak with your pharmacy team in the first instance. If you have concerns about a medicine, you may be using, please contact 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
The quality of medicine has not been affected, therefore patients do not need to take any action. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.
Patients should be aware that the Patient Information Leaflet (PIL) included in the packs of the above specified batches of medicines does not contain the most up to date safety information. The affected sections of the PIL are included in the table under ‘Brief description of the problem’. The up-to-date version of the Patient Information Leaflet can be accessed via the links below. Please read this before taking the medicine.
Rabeprazole sodium 10mg gastro-resistant tablets
Rabeprazole sodium 20mg gastro-resistant Tablets
If you have any concerns about the information provided with your medicine, please speak with your pharmacy team in the first instance. If you have concerns about a medicine, you may be using, please contact 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 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.