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The Department of Health (DH) today (April 8) endorsed the recall of affected batches of a pharmaceutical product called "Multi-12 For IV Infusion" (Registration number: HK-53536) by its wholesaler as the batches were not manufactured in line with approved procedure.
The recall is initiated by a licensed drug wholesaler, Baxter Healthcare Limited (Hong Kong) (Baxter) after the product's manufacturer, Sandoz Canada, reported that it had used purified water instead of water for injection to mix an active ingredient in certain batches. Internal investigation by the manufacturer so far shows that the affected batches met other specifications, including sterility and endotoxin levels.
"Multi-12 For IV Infusion" is used in patients with need for vitamin supplement. These include those on parenteral nutrition and those after surgery, have extensive burns or fractures.
"According to Sandoz Canada and confirmed by Baxter's record, two of the affected batches, 157483 and BC7364, have been imported into Hong Kong. These were subsequently supplied to private hospitals and private practitioners, and will now be recalled from them," a DH spokesman said.
He added that DH has received no notification of related adverse report, agrees with the proposal and will continue to investigate into the cause of the problem.
It is understood that Baxter will set up a hotline at 6113 1027 to answer related enquiries.
The spokesman urged all healthcare providers who have the above quoted stock in hand to stop supplying the product further and get in touch with the wholesaler. They are also requested to report suspected adverse events to the DH.
In connection, members of the public are advised to consult their healthcare providers when in doubt and in particular if they feel unwell after having used the product.
Ends/Friday, April 8, 2011
Issued at HKT 20:28
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