Class 4 Medicines Defect Information: Viatris UK Healthcare Ltd

Class 4 Medicines Defect Information: Viatris UK Healthcare Ltd, Omeprazole 40 mg Powder for solution for infusion, EL(24)A/54

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.

DMRC/MDR Number: DMRC-32786665

Company name: Viatris UK Healthcare Ltd

Product description: Omeprazole 40 mg Powder for solution for infusion, PL 04569/1022 SNOMED Code 35775411000001106

Details of the affected batch: 

Brief description of 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 the recall notification.

Advice to 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.

Advice to 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.

Company contacts for further information:

For medical information and stock control queries please contact:

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).

To access the full recall: Class 4 Medicines Defect Information: Viatris UK Healthcare Ltd, Omeprazole 40 mg Powder for solution for infusion, EL(24)A/54