MHRA Class 4 Medicines Defect Information: Omeprazole 40mg Powder for solution for infusion (Viatris UK Healthcare Ltd)
MHRA Class 4 Medicines Defect Information: Omeprazole 40mg Powder for solution for infusion (Viatris UK Healthcare Ltd)
Drug alert number: EL (24)A/54
Date issued: 12 November 2024
The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for: Omeprazole 40mg Powder for solution for infusion.
Company name: Viatris UK Healthcare Ltd
Product name: Omeprazole 40mg Powder for solution for infusion, PL 04569/1022
SNOMED Code: 35775411000001106
| Batch Number | Expiry Date | Pack Size | First Distributed |
| C017 | Feb-25 | 5 | 19-Nov-23 |
| D006Y | Jun-25 | 5 | 01-Mar-24 |
Brief description of the problem
Generics (U.K.) Limited (Marketing Authorisation Holder), a Viatris UK Healthcare Limited company, has informed the MHRA that the Patient Information Leaflet (PIL) packaged in the above specified batches of Omeprazole 40 mg Powder for solution for infusion do not contain the most up to date safety information. The affected sections of the PIL are summarised in Appendix 1 of this notification.
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.
View full alert here.
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 the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Further Information
Viatris UK Healthcare Limited Medical Information at +44 (0)1707 853 000 (select option 1) or info.uk@viatris.com. Customer Services can be reached at +44 (0)1707 853 000 (select option 2).
