Fresenius Kabi Limited are recalling a specific batch of sodium bicarbonate 1.26% solution for infusion 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 the 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.
Further information, details of the affected batch and advice for healthcare professionals is available on the MHRA website.