Baxter recalls two lots of Extraneal peritoneal dialysis solution because of high levels of sodium hydroxide, which may pose serious health risks

Starting date:
March 23, 2019
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public
Identification number:
RA-69410

Last updated:

Update – May 1, 2019
Baxter Corporation has issued a notice to customers indicating that one of the recalled lots (Extraneal 2L/2L Twinbag, product code JB9912, lot number W9B28T0), may have also been distributed on March 21, 2019, in addition to March 14-20, 2019, as indicated below. No additional lots are being recalled.

Update – March 27, 2019
Baxter Corporation has issued a correction that the two lots were recalled because of high levels of “sodium hydroxide,” not “sodium hypochlorite” as previously indicated. All references to “sodium hypochlorite” in the March 23, 2019, advisory below have been corrected to “sodium hydroxide.”

March 23, 2019
For immediate release

OTTAWA – Health Canada is advising Canadians that Baxter Corporation is voluntarily recalling two lots of Extraneal peritoneal dialysis solution as a precautionary measure because of high levels of sodium hydroxide.

Use of the affected product in patients could cause chemical peritonitis. Chemical peritonitis is the inflammation of the peritoneum (the lining of the abdomen and pelvis), which can be serious if not promptly treated. Symptoms include nausea, vomiting and abdominal pain or tenderness. The high levels of sodium hydroxide are found in the active pharmaceutical ingredient icodextrin, and can cause discolouration of the solution.

Extraneal is a sterile peritoneal dialysis solution used for patients whose kidneys are not working properly. The dialysis solution is used in hospitals and home settings. The lots affected by this recall were distributed by Baxter between March 14, 2019 and March 20, 2019.

Affected products
Product DIN Product Code Lot Expiry
Extraneal 2L/2L Twinbag 02240806 JB9912 W9B28T0 02/29/2020
Extraneal 7.5% 2.5L SYSII 02240806 JB9923LP W9C05T1 03/31/2020

 

What you should do

  • Immediately examine your stock to determine whether you have product from the affected lot. The product code and lot number can be found on the individual product or shipping carton.
  • If you have affected product, speak to your healthcare provider immediately regarding replacement product.
  • Contact Baxter Corporation Customer Care at 1-866-968-7477 for instructions on how to return the recalled product.
  • Talk to your doctor or nurse if you have used product from the affected lot.
  • Report any health product-related adverse reactions or complaints to Health Canada.

Who is affected

Canadians who have product from the affected lots.

Media enquiries

Health Canada
(613) 957-2983
hc.media.sc@canada.ca

Public enquiries

Public Enquiries:

(613) 957-2991
1-866 225-0709

What Health Canada is doing

Health Canada is monitoring the recall. Should Health Canada become aware of additional safety information, we will take appropriate action and inform Canadians as necessary.