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The Department of Health (DH) today (April 7) instructed licensed drug wholesaler, Sanofi-Aventis Hong Kong Limited, to recall 12 batches of a pharmaceutical product called "Lasix 250mg/25ml injection" (Registration number: HK-05566) from market because of potential safety issue.
The recall followed findings by the product's German manufacturer, Sanofi-Aventis Deutschland GMBH that during their ongoing stability tests, visible particles were found in some ampoules of certain batches produced after more than 18 months.
"Lasix 250mg/25ml injection", a prescription drug, is a diuretic indicated for the treatment of acute or chronic renal insufficiency and oliguria. It can only be sold under the supervision of a pharmacist with prescription.
According to the information provided by the manufacturer, among the imported batches, a total of 12 batches of the product were manufactured more than 18 months. Only one batch was found to contain visible particles. However, as a precautionary measure, the wholesaler is requested to recall the 12 batches from the market.
The batch numbers of the batches under recall are 40N919, 40N934, 40N941, 40B115, 40B128, 40B149, 40U215, 40U228, 40U245, 40C311, 40C337 and 40C369. The products have been supplied to hospitals and medical practitioners.
Healthcare providers in reception of the 12 batches should stop immediately supplying the batches further.
As there is no other replacement medicines in the market, healthcare workers should be vigilant and check for visual particles before supplying and using other batches of the product to their patients. They are also requested to report related adverse events to the DH.
Sanofi-Aventis Hong Kong Limited has set up a 24-hours hotline for enquiry (9316 7212).
No adverse effects related to the product were received by the DH so far. DH investigation continues.
Members of the public should consult their healthcare providers if in doubt or feel unwell after using the product.
Ends/Thursday, April 7, 2011
Issued at HKT 21:40
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