The Department of Health (DH) today (June 3) instructed the Baxter Healthcare Ltd., a licensed drug wholesaler, to recall three batches of Potassium Chloride Injection 20mEq/100ml (Registration No. HK-56421, Batch Nos: P259705, P259705A, P263673) as the endotoxin level exceeded the product specification limits.
According to Baxter, the product was manufactured in the United States. So far, investigations by Baxter suggested that there was an error in test data interpretation when calculating the bacterial endotoxin test values on routine testing, resulting in lower than actual endotoxin values obtained.
Investigation so far revealed that raw materials met the requirements for endotoxin testing.
Nevertheless, as elevated endotoxins in the product may cause fever and in serious cases, cause septic shock, Baxter is instructed to recall the affected batches of the product as a precautionary measure.
Potassium Chloride Injection is indicated for the treatment of potassium deficiency. According to Baxter, around 2 300 bags of the affected batches were imported into Hong Kong and around 1 200 bags have been supplied to public hospitals.
So far, no adverse report has been received. Baxter has set up a hotline, 6113 1027, for enquiries.
The DH spokesman urged healthcare professionals to stop using the affected batches of the product. DH will closely monitor the recall and development.
(Reprinted from HKSAR Government web page
http://www.info.gov.hk/gia/general/201106/03/P201106030304.htm )