The Department of Health (DH) today (June 18) endorsed a licensed drug wholesaler, LF Asia (Hong Kong) Limited - Healthcare Division, to conduct a voluntary recall of four batches (batch numbers: 042265AD, 042270AD, 042270AD1 and 042270AD2) of Ambisome for Injection 50mg (registration number: HK-43591) from the market due to a potential quality issue.
LF Asia notified the DH today that the product's manufacturer in Ireland, Gilead Sciences Limited, detected contamination at the manufacturing facility during its routine process sterility testing. Although so far none of the Ambisome injection was found to be contaminated, the manufacturer initiated a worldwide recall of all 20 affected batches manufactured since July 2012 as a precautionary measure. The DH has asked the manufacturer to provide a full investigation report about the incident.
The DH's investigation is continuing.
According to LF Asia, four affected batches of Ambisome for Injection 50mg were imported into Hong Kong since January 2013. About 3 000 affected bottles were supplied to the Hospital Authority and private hospitals, local pharmacies and private doctors. LF Asia has informed all affected customers about the recall.
So far, the DH has not received any adverse reaction report related to the use of the product.
Ambisome for Injection 50mg, containing amphotericin B, is an antifungal agent used for the treatment of severe fungal infections. Side-effects include lack of appetite, nausea and vomiting, diarrhoea, headache and muscle pain. It is a prescription medicine and can only be used under medical advice.
LF Asia has set up a hotline, 3129 2037, to answer public enquiries. The DH will closely monitor the recall.
Members of the public who are in doubt should seek advice from their health-care providers.
LF Asia notified the DH today that the product's manufacturer in Ireland, Gilead Sciences Limited, detected contamination at the manufacturing facility during its routine process sterility testing. Although so far none of the Ambisome injection was found to be contaminated, the manufacturer initiated a worldwide recall of all 20 affected batches manufactured since July 2012 as a precautionary measure. The DH has asked the manufacturer to provide a full investigation report about the incident.
The DH's investigation is continuing.
According to LF Asia, four affected batches of Ambisome for Injection 50mg were imported into Hong Kong since January 2013. About 3 000 affected bottles were supplied to the Hospital Authority and private hospitals, local pharmacies and private doctors. LF Asia has informed all affected customers about the recall.
So far, the DH has not received any adverse reaction report related to the use of the product.
Ambisome for Injection 50mg, containing amphotericin B, is an antifungal agent used for the treatment of severe fungal infections. Side-effects include lack of appetite, nausea and vomiting, diarrhoea, headache and muscle pain. It is a prescription medicine and can only be used under medical advice.
LF Asia has set up a hotline, 3129 2037, to answer public enquiries. The DH will closely monitor the recall.
Members of the public who are in doubt should seek advice from their health-care providers.
Reprinted from HKSAR Government:
http://www.info.gov.hk/gia/general/201306/18/P201306180623.htm