30th July 2024
Dear Customer,
Fresenius Kabi Limited has issued a Class 4 Medicines Defect Information – Caution in Use. In relation to
Hartmann’s Solution for Injection BP as Steriflex No. 11 or freeflex PL 08828/0083
Brief description of the 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).
The following details how the affected batches purchased through NVS were sold as
|
NVS Product Code(s) |
Product Description | Affected Batch Number(s) | Expiry Date |
| 951651 | HARTMANNS SOLUTION (FREEFLEX), 500ml | 14TB7322 | 18/02/2027 |
Advice for 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.
What to do next – Please read the attached notification letter (Please click here) and bring the issue to the attention of all relevant colleagues within your business
