Other safety alerts
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The United Kingdom: Class 4 Drug Alert, certain Baxter Potassium Chloride containing intravenous infusions |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Baxter Healthcare Limited has informed that a quality defect has been identified with the following 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 products formulation which is a risk-mitigating factor in the prevention of a potential mix-up with other solutions for infusion. The affected products are:
- Potassium Chloride 0.15% w/v and Glucose 10% w/v Solution for Infusion, 500ml
- Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Solution for Infusion – BP, 1000ml
- Potassium Chloride 0.3% w/v and Sodium Chloride 0.9% w/v Solution for Infusion, 1000ml
For details of the affected products, please refer to the website in MHRA.
Healthcare professionals are advised:
- Please check their complete inventory of the above products and inspect the print on each bag to ensure the presence of the red print. This includes stock within their pharmacy, on wards and at any other relevant location within their hospital.
- Please consider the possibility that the absence of red text may have resulted in units being stored in the incorrect location so please ensure that all locations where infusion bags are stored are checked.
- If units have been supplied to any other facilities or departments within their institution, please forward a copy of this letter to them.
- If they have any home patients who use these products, please notify them.
- Should any units be identified without the red print, please place those units in quarantine and notify Baxter.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-drug-alert-certain-baxter-potassium-chloride-containing-intravenous-infusions
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Tuesday, Jun 4, 2019
Issued at HKT 16:00
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