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The Department of Health (DH) today (March 8) instructs a licensed drug wholesaler, Hong Kong Red Cross Blood Transfusion Service (HK Red Cross), to recall all Albumex 5 Infusion 12.5g/250ml (HK-58570) and Albumex 20 Infusion 10g/50ml (HK-58571), due to quality issue.
Today, DH received notification from the HK Red Cross that they were informed by the product manufacturer in Australia, CSL Limited, that some of the Albumex products were found contaminated with ethylene glycol after a follow up investigation of a small leak of ethylene glycol (in late January 2012) in a pasteurisation vessel used in the manufacture of the products.
Albumex 5 Infusion and Albumex 20 Infusion, containing human albumin, are used for shock or in plasma exchange. They can only be sold on prescription and under the supervision of pharmacists at registered pharmacies.
Ethylene glycol is a substance used to control temperature during the manufacturing process. Toxic effects of ethylene glycol include central nervous system effects similar to ethanol, anion gap metabolic acidosis, and acute renal failure. Toxicity due to ethylene glycol occurs acutely and delayed effects beyond 72 hours would not be expected.
CSL Limited claimed that the levels of contamination which have been detected are very low and that, based on projections of the highest possible amounts administered and available toxicological data, adverse clinical effects appear unlikely to occur. The Australian regulatory authority is undertaking the safety assessment of the products. DH will contact the Australian regulatory authority for their assessment. DH investigation continues.
A DH spokesman says, "DH has not received any adverse event report in connection with the products so far."
According to HK Red Cross, the products were supplied to the Hospital Authority and private hospitals. The concerned hospitals had been informed and the products had already been quarantined.
HK Red Cross has set up a hotline (2710 1222) to answer related enquiries. DH will closely monitor the recall.
The spokesman says, "Here, contravention of Section 52(1) of the Public Health and Municipal Services Ordinance (Cap 132), selling drug not of the nature, substance or quality demanded by the purchaser, might have occurred. The maximum penalty involved is $10,000 and three months' imprisonment. DH will seek the Department of Justice's advice on further action on completion of the investigation."
"Members of the public who have used the products should seek advice from their healthcare professionals if in doubt or feeling unwell," the spokesman urges.
Ends/Thursday, March 8, 2012
Issued at HKT 21:30
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