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| Singapore : Recall of one batch of Dianeal Low Calcium (2.5 MEQ／L) Peritoneal Dialysis Solution with 2.5% Dextrose (2L／2L), Ultrabag (English only) |
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The Health Sciences Authority (HSA) announces that Baxter Healthcare (Asia) Pte Ltd is recalling one batch of Dianeal Low Calcium (2.5 MEQ/L) Peritoneal Dialysis Solution with 2.5% Dextrose (2L/2L), Ultrabag (Batch Number: S20A25012) at consumer level due to leakage of solution and excess water in the over pouch.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/product-recall/recall-of-one-batch-of-dianeal-low-calcium-(2.5-meq-l)-peritoneal-dialysis-solution-with-2.5-dextrose-(2l-2l)-ultrabag
In Hong Kong, there are 3 registered pharmaceutical products containing the same active ingredients as the above recalled product in Singapore, namely DIANEAL LOW CALCIUM PERITONEAL SOLN 2.5% (HK-35012), DIANEAL LOW CA P.D. SOLN W/2.5% DEXTROSE (HK-42531), and DIANEAL LOW CALCIUM PERITONEAL DIALYSIS SOLUTION WITH 2.5% DEXTROSE (ULTRA BAG) (HK-62709). All the three products are registered by Baxter Healthcare Ltd (Baxter); and are prescription-only medicines. As confirmed with Baxter, the product under HK-35012 has never been imported into Hong Kong. For the products under HK-42531 and HK-62709, they are manufactured by a different manufacturer and the recall in Singapore has no impact on the products marketed in Hong Kong.
Ends/ Tuesday, December 8, 2020
Issued at HKT 15:45
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