Press Release
Recall of B Braun Sodium Bicarbonate 8.4% Infusion
26 Mar 2012
The Department of Health (DH) today (March 26) instructs a licensed drug wholesaler, B Braun Medical (HK) Limited (B Braun), to recall from shelf one batch (Batch number: 111358021) of its Sodium Bicarbonate 8.4% w/v Infusion (registration number: HK-28230) as part of a global act due to suspected quality defect.
Through its surveillance scheme, DH learns that the United Kingdom's drug authority, Medicines and Healthcare products Regulatory Agency, has announced recall of one batch of the above product because precipitation is detected in some items. The act is in response to a global recall initiated by the product's manufacturer in Germany, B Braun Medical Melsungen.
Sodium Bicarbonate 8.4%w/v Infusion is an intravenous solution primarily indicated for metabolic acidosis and urine alkalisation.
"According to B Braun Medical Melsungen's latest in-house finding, the precipitation is likely to be aluminium salt. However, the root cause remains to be worked out," a DH spokesman reveals.
"The precipitation tends to flocculate in aggregates of different sizes and could cause or contribute to the development and worsening of adverse effects such as embolism," the spokesman further deliberates.
"In Hong Kong, investigation thus far shows that of the two batches under global recall, namely batch 111358021 and batch 111028022, B Braun has only imported the former into Hong Kong in 2011. The product was then supplied to hospitals under the Hospital Authority (HA), private hospitals, public and private clinics, and also exported to Macau," the spokesman continues to explain.
"As time is needed for further investigation, including liaison with other counterparts abroad, DH opts after risk assessment that while the affected batch imported must be recalled, healthcare professionals should balance the risk of adverse effects against the benefit of treatment for other batches of the infusion in hand, especially when alternatives are not readily available to meet immediate patient need," the spokesman stresses.
"While we have already alerted the various parties which have received the affected batch, as a fact, no adverse report in relation to the product has been received by DH yet," the spokesman remarks.
B Braun has already set up a hotline at 2277 6100 to answer related enquiries.
"Here, contravention of the Public Health and Municipal Ordinance (Cap 132), selling a drug not of the nature, substance or quality demanded by the purchaser, might have occurred. The maximum penalty involved is a fine of HK$10,000 and three months' imprisonment. DH will seek Department of Justice's advice on completion of our investigation," the DH spokesman states.
"Members of the public who have used the product should consult their healthcare providers if in doubt or feeling unwell," the spokesman adds.
