Other safety alerts
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| The United Kingdom: Class 4 Medicines Notification: Fresenius Kabi Limited, Sodium Chloride Intravenous Infusion 0.9% Freeflex |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Fresenius Kabi Limited has informed the MHRA of an error on the infusion bag packaged into 4 batches of Sodium Chloride Intravenous Infusion 0.9% Freeflex (batch number: 13SMR091, 13SMR061, 13TAR011, 13SLR271). The error has been identified in the contents box (active substance section). It is incorrectly printed ‘Each 50 ml contains approx’; this should state ‘Each 100 ml contains approx’. The correct quantity is stated on the outer carton and in the Summary of Product Characteristics.
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 administering this product, particularly when performing electrolyte or dilution calculations.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-notification-fresenius-kabi-limited-sodium-chloride-intravenous-infusion-0-dot-9-percent-freeflex-el-24-a-slash-10
In Hong Kong, Sodium Chloride For Intravenous Infusion 0.9% w/v (HK-62156), Sodium Chloride Kabi Solution For Infusion 0.9% w/v (HK-67667) and Sodium Chloride Fresenius Solution For Infusion 0.9% w/v (HK-67867) are pharmaceutical products registered by Fresenius Kabi Hong Kong Limited (Fresenius Kabi). All products are prescription-only medicines. As confirmed with Fresenius Kabi, the affected batches have not been imported into Hong Kong.
Ends/Friday, Mar 22, 2024
Issued at HKT 15:30
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