Batch Recall of Extraneal Peritoneal Dialysis Solution with 7.5% Icodextrin

20 November 2020
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The Department of Health (DH) today (November 20) endorsed a licensed medicine wholesaler, Baxter Healthcare Ltd. (Baxter), to recall a batch (lot number: S20A31028) of Extraneal Peritoneal Dialysis Solution with 7.5% Icodextrin (Hong Kong Registration Number: HK-46627) from the market due to a potential quality issue.

The DH received notification from Baxter that complaints of leakage were received overseas with excessive liquid found in the over pouch of the product. Based on manufacturer’s investigation, it was concluded that the problem was specific to the tubing used to manufacture the aforementioned batch of product. There is no similar complaint received in Hong Kong, however, leakage of a peritoneal solution bag might lead to contamination of the fluid inside. As a precautionary measure, Baxter is recalling the affected batch of the product from the market.

The above product, containing icodextrin and electrolytes, is a peritoneal dialysis solution. According to Baxter, the affected batch was all supplied to the Hospital Authority between Feb to Mar 2020. According to the Hospital Authority, most of the products of the affected batch have been used.

Baxter has set up a hotline (2350 2688) to answer related enquiries.

So far, the DH has not received any adverse reaction report in connection with the affected product. The DH will closely monitor the recall.

Patients who require use of the above product should seek advice from their healthcare professionals for appropriate arrangements. There are other batches of the product available on the market.

Reposted from HKSAR Government webpage:
https://www.drugoffice.gov.hk/eps/news/showNews/Batch+Recall+of+Extraneal+Peritoneal+Dialysis+Solution+with+7.5%25+Icodextrin/pharmaceutical_trade/2020-11-20/en/42288.html