Class 2 Recall - Sodium bicarbonate 1.26% Solution for infusion 500ml

Fresenius Kabi Limited are recalling the below batch of product as a precautionary measure due to the identification of particles in the solution for infusion, following routine batch analysis and subsequent batches manufactured on the same filling line. The company’s investigation indicates that he particles appear to originate from the interaction between the equipment and the packaging material during the filling process. The integrity of the packaging and sterility of the product are not compromised.

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-fresenius-kabi-limited-sodium-bicarbonate-1-dot-26-percent-solution-for-infusion-el-22-a-slash-20?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=ca886a23-3a40-4c69-811e-b116b6a59264&utm_content=immediately

Further Information

For more information, medical or supply enquiries, please contact 01928 533 758 FK.Complaints-UK@fresenius-Kabi.com or Customer.Services-UK@Fresenius-Kabi.com  

Please return all affected stock to your original supplier for credit. Unfortunately we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.