Class 2

Class 2 Medicines Recall: Fresenius Kabi Limited, Sodium bicarbonate 1.26% Solution for infusion, EL(22)A/20

Class 2 Medicines Recall: Fresenius Kabi Limited, Sodium bicarbonate 1.26% Solution for infusion, EL(22)A/20

Fresenius Kabi Limited are recalling a specific batch of product as a precautionary measure due to the identification of particles in the solution for injection, following routine batch analysis and subsequent batches manufactured on the same filling line.

MDR Number: MDR 176-04/22

Company name: Fresenius Kabi Limited

Product description: Sodium bicarbonate 1.26% Solution for infusion PL 08828/0013

Details of the affected batch:

Batch number

Expiry date

Pack size

First distributed

22BC01

02/2023

500ml

31st March 2022

Active Pharmaceutical Ingredient: sodium bicarbonate

Brief description of problem:

Fresenius Kabi Limited are recalling the above 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 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.

Advice to Healthcare Professionals:

Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process. Healthcare professionals are advised to monitor patients where appropriate and report suspected adverse events to the company or via the MHRA Yellow Card scheme.

Company contacts for 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.

Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Full recall