Class 4 MHRA drug alert – Baxter Healthcare Limited, Potassium Chloride Products

Class 4 MHRA drug alert – Baxter Healthcare Limited, Potassium Chloride Products

June 3, 2019

Drug alert number: EL(19)A/13

Date issued: 3rd June 2019

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 pharmacy level caution in use for:

Baxter Healthcare Limited

Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Solution for Infusion – BP, 1000ml, Product code FKE1764 (PL 00116/0336)

Potassium Chloride 0.3% w/v and Sodium Chloride 0.9% w/v Solution for Infusion, 1000ml, Product Code FKE1984 (PL 0116/0337)

Potassium Chloride 0.15% w/v and Glucose 10% w/v Solution for Infusion, 500ml, Product Code FE3737 (PL 0116/0656)

Baxter Healthcare Limited has informed the MHRA, that a quality defect has been identified with the above products where the front panel of a small number of infusion bags was found to be missing the red text. The red text highlights the presence of potassium chloride in the product formulation which is a risk-mitigating factor in the prevention of a potential mix-up with other solutions for infusion.

To view a list of affected batches, see appendix 1 of the full alert.

Should any units be identified without the red print, please place those units in quarantine and notify Baxter by email: uk_shs_qa_complaints@baxter.com or by telephone: 01604 704 603
(Baxter reference number: FA-2019-026).

PL numbers: PL 00116/0336, PL 0116/0337, PL 0116/0656

To view the alert please visit the GOV.uk website.



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