Medicines defect noticeMHRA
Omeprazole 40 mg Powder for solution for infusion defect notice over a packaging defect
Generics (U.K.) Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in specific batches of Omeprazole 40 mg Powder for solution for infusion 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.
7 identifiers listed for this notice.
Omeprazole 40 mg Powder for solution for infusion 5
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- C017
- D006Y
- Product licenceThe PL number on the carton.
- PL 04569/1022
- ExpiryOn the carton, blister or label.
- Feb-25
- Jun-25
- First distributedOn the product, its label or its packaging.
- 19-Nov-23
- 01-Mar-24
What to do now
The problem with Omeprazole 40 mg Powder for solution for infusion is the pack or device, such as a syringe, cap, blister or inhaler.
- 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. 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
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(24)A/54). Quoted as issued.
Summary
Generics (U.K.) Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in specific batches of Omeprazole 40 mg Powder for solution for infusion do not contain the most up to date safety information.
The risk
DMRC reference number DMRC-32786665 Company name
Advice for healthcare professionals
There is no risk to the product quality of the medicine listed in this notification. Viatris UK Healthcare Ltd has confirmed that all future batches of the product will contain the updated PIL.
Healthcare professionals are advised to ensure that patients are aware of the updated safety information before administering the product 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 versions of the PIL are up to date:
Omeprazole 40 mg, powder for solution for infusion. - Patient Information Leaflet (PIL)
Hard copies of the updated PIL can also be requested from Viatris UK Healthcare Ltd (see contact details below) so that current stock in the dispensary can be supplemented with the correct PIL.
The medicine itself is not affected and patients do not need to take any action. Patients should continue to receive this medicine from these batches as given to you by your healthcare professional.
Patients should be aware that the Patient Information Leaflet included in the packs of the above specified batches of medicines does not contain the most up to date safety information. The affected information is summarised in Appendix 1 of this notification. Your healthcare professional will ensure that you have access to the most up-to-date information associated with the medicines you are receiving.
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
The medicine itself is not affected and patients do not need to take any action. Patients should continue to receive this medicine from these batches as given to you by your healthcare professional.
Patients should be aware that the Patient Information Leaflet included in the packs of the above specified batches of medicines does not contain the most up to date safety information. The affected information is summarised in Appendix 1 of this notification. Your healthcare professional will ensure that you have access to the most up-to-date information associated with the medicines you are receiving.
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 Omeprazole 40 mg Powder for solution for infusion been recalled?
The problem with Omeprazole 40 mg Powder for solution for infusion is the pack or device, such as a syringe, cap, blister or inhaler. 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, 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?
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.