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Batch recall of B Braun Sodium Bicarbonate 8.4% Infusion (with photo)

     The Department of Health (DH) today (December 3) endorsed a licensed drug wholesaler, B Braun Medical (HK) Limited (B Braun), to recall eight batches of Sodium Bicarbonate 8.4% Infusion (Registration Number: HK-28230) due to a potential quality issue.

     The batches under recall are: 121148021, 121838022, 122648022, 123518022, 124118082, 130568022, 131048021 and 131558022.

     The DH received notification from B Braun today that the company is conducting a voluntary recall of certain batches of the above product globally as precipitation was detected in some samples during a regular visual inspection conducted by the manufacturer.

     Sodium Bicarbonate 8.4% Infusion is an intravenous solution indicated for urine alkalization and metabolic acidosis. According to B Braun's preliminary findings, the precipitation was probably due to the leaching of compounds from the stopper of the product container, which has been in use since March 2012.

     The presence of precipitation in the infusion product may cause or contribute to the development of adverse effects such as embolism. As a precautionary measure, B Braun has recalled all batches of the product that use the same stopper. The DH has requested B Braun to provide a detailed investigation report about the issue as soon as possible.

     According to B Braun about 57,400 bottles of the affected batches were supplied to Hospital Authority and private hospitals, private doctors as well as exported to Macau.

     So far, no adverse report in relation to the product has been received by the DH. The DH will closely monitor the recall.

     B Braun has set up a hotline on 2277 6100 to answer related enquiries.

     "Healthcare providers should stop supplying the batches concerned to their clients," a DH spokesman remarked.

Ends/Tuesday, December 3, 2013
Issued at HKT 19:28


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