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The Department of Health (DH) today (December 21) endorsed a licensed drug wholesaler, B. Braun Medical (H.K.) Limited (B. Braun) to recall from the market three Nutriflex Lipid products because of potential particulate formation in the products.
The DH received notification from B. Braun of the global recall of "Nutriflex Lipid Peri Emulsion for Infusion" (HK-50080), "Nutriflex Lipid Plus Emulsion for Infusion " (HK-50081) and "Nutriflex Lipid Special Emulsion for Infusion" ( HK-50103) manufactured in its German manufacturer, B. Braun Melsungen AG.
According to the information provided by B. Braun so far, the recall was initiated because the stability testing on the above products had identified potential particulate formation over time. Initial findings indicated that the cause could be due to a failure in the production line and the process of the production of the empty bag, which holds the product.
DH investigation continues.
Nutriflex Lipid products are used for parenteral nutrition therapy.
According to the company, the affected products were imported and supplied to public and private hospitals, veterinary clinics and exported to Macao.
So far, no adverse reports in relation to the products have been received.
B. Braun has set up a hotline 6280 7451 to answer related enquiries.
DH has already alerted the Hospital Authority, private hospitals, professional healthcare bodies about the matter and will closely monitor the recall.
Healthcare professionals are advised to stop using the products and monitor their patients for adverse events.
Ends/Wednesday, December 21, 2011
Issued at HKT 20:19
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