Class 4 Medicines Defect Information: Fresenius Kabi Limited

Class 4 Medicines Defect Information: Fresenius Kabi Limited, Hartmann's Solution for Injection BP as Steriflex No. 11 or freeflex, EL(24)A/31

Fresenius Kabi Limited has informed the MHRA of a labelling error on the packaging of Hartmann’s solution for Injection BP as Steriflex No.11 or freeflex.

DMRC Number: DMRC 31178038

Company name: Fresenius Kabi Limited

Product description: Hartmann’s Solution for Injection BP as Steriflex No. 11 or freeflex, PL 08828/0083 SNOMED Code 4900111000001102

Details of the affected batches: 

Brief description of problem:

Fresenius Kabi Limited has informed the MHRA of a labelling error on the packaging of Hartmann’s solution for Injection BP as Steriflex No.11 or freeflex. The calcium content in the active ingredient section of the infusion bag label is incorrectly stated as ‘12 mmol/500 mL’; this should state ‘1 mmol/500 mL’.

The calcium content is stated correctly on the outer carton, and the infusion bags contain the correct amount of calcium (1 mmol/500 mL). 

Advice to Healthcare Professionals:

The quality of the product is not impacted by this labelling error; therefore, the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when supplying and when administering the product.

Fresenius Kabi Limited has confirmed that all production of future batches will contain the correct calcium content stated on the infusion bag. However, batch 14TE7326, which has yet to be distributed, will not be repackaged to avoid any supply concerns.

Advice to Patients:

No action is needed from patients. Patients should continue to receive this medicine from these batches as given to you by your healthcare professional. There is no impact to product quality.

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.

Company contacts for further information:

For more information or medical information queries please email Medical.Information-UK@fresenius-kabi.com or telephone 01928533575.

For stock control enquiries please contact  FK.complaints-uk@fresenius-kabi.com or telephone 01928 533758.

To access the full recall: Class 4 Medicines Defect Information: Fresenius Kabi Limited, Hartmann’s Solution for Injection BP as Steriflex No. 11 or freeflex, EL(24)A/31