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 reference number
DMRC 31178038
Company name
Fresenius Kabi Limited
Hartmann’s Solution for Injection BP as Steriflex No. 11 or freeflex, PL 08828/0083
SNOMED Code
4900111000001102
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 14TB7322 | 18/02/2027 | 20 x 500 ml | 13/04/2024 |
| 14TD7312 | 02/04/2027 | 20 x 500 ml | 09/07/2024 |
| 14TE7326 | 20/05/2027 | 20 x 500 ml | Not yet distributed |
Active Pharmaceutical Ingredient: sodium chloride, potassium chloride, calcium chloride dihydrate, sodium lactate
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).
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.
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 for 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.
Further Information
For more information or medical information queries please email
Medical.Information-UK@fresenius-kabi.com or telephone +44 (0) 1928533575.
For stock control enquiries please contact FK.complaints-uk@fresenius-kabi.com or telephone +44 (0) 1928 533758.
Recipients of this Medicines Notification 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.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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