The Department of Health (DH) today (July 11) endorsed a licensed drug wholesaler, Baxter Healthcare Ltd (Baxter), to recall from the healthcare sector one batch (batch number: P309187) of 0.9% Sodium Chloride Injection (50ml) (Hong Kong registration number: HK-20984) due to particulate matter found in the product.
The DH received notification from Baxter today that the manufacturer in the United States (US) was conducting a voluntary recall of the affected batch globally following a complaint of particulate matter found in one packet of the above product. Particulates, if infused, may cause blockage of blood vessels which can result in stroke, heart attack or damage to other organs such as the kidney or liver. Allergic reactions, local irritation and inflammation are also possible. No adverse events in connection with this issue have been reported.
0.9% Sodium Chloride Injection is indicated as a source of water or electrolytes for medical treatment.
Preliminary investigation by the manufacturer in the US indicated that the particulate matter might have been introduced into the product during the production of the plastic container. So far, there is no evidence to suggest that other batches of the product were affected.
"Locally, according to Baxter, 49 cartons (each with 96 packets) of the affected batch have been supplied to the Hospital Authority, private hospitals and private doctors. The DH has not received any adverse reports related to this product so far," a spokesman for the DH said.
Baxter has set up a hotline (2807 8500) to answer related enquiries. The DH will closely monitor the recall.
"Healthcare providers should visually inspect for any particulate matter before using the product and other injectable drugs. If particulates or suspicious matters are found, they should immediately stop using it and report the case to the supplier," the spokesman advised.
The DH received notification from Baxter today that the manufacturer in the United States (US) was conducting a voluntary recall of the affected batch globally following a complaint of particulate matter found in one packet of the above product. Particulates, if infused, may cause blockage of blood vessels which can result in stroke, heart attack or damage to other organs such as the kidney or liver. Allergic reactions, local irritation and inflammation are also possible. No adverse events in connection with this issue have been reported.
0.9% Sodium Chloride Injection is indicated as a source of water or electrolytes for medical treatment.
Preliminary investigation by the manufacturer in the US indicated that the particulate matter might have been introduced into the product during the production of the plastic container. So far, there is no evidence to suggest that other batches of the product were affected.
"Locally, according to Baxter, 49 cartons (each with 96 packets) of the affected batch have been supplied to the Hospital Authority, private hospitals and private doctors. The DH has not received any adverse reports related to this product so far," a spokesman for the DH said.
Baxter has set up a hotline (2807 8500) to answer related enquiries. The DH will closely monitor the recall.
"Healthcare providers should visually inspect for any particulate matter before using the product and other injectable drugs. If particulates or suspicious matters are found, they should immediately stop using it and report the case to the supplier," the spokesman advised.
Reprinted from HKSAR Government:
http://www.info.gov.hk/gia/general/201407/11/P201407110983.htm