CLINOLEIC 20% - Potential for the Presence of Particles from the Administration Port Material - For the Public

Starting date:

July 16, 2013

Posting date:

July 16, 2013

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

General Public

Identification number:

RA-34661

This is duplicated text of a letter from the Baxter Corporation. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

PUBLIC COMMUNICATION - Health Canada Endorsed Important Safety Information on CLINOLEIC (Refined Olive Oil and Refined Soybean Oil Lipid Emulsion) 20%

July 16, 2013

Dear Customers and Patients,

Subject: Potential for particles from the administration port material being present in CLINOLEIC 20% - Product Codes CJDB9501 250 mL, CJDB9503 500 mL, CJDB9504 1000 mL

Baxter Corporation and Health Canada are providing you this Important Safety Information as there is a possibility of creating particles from the administration port material while the pharmacy prepares your Parenteral Nutrition (PN) prescription using CLINOLEIC 20%.

• During the preparation of your PN prescription, particles from the bag material may have entered CLINOLEIC 20% solution.
• In the event that particles enter the parenteral nutrition tubing, there is the potential for patient injury including the risk of blocked blood vessels.
• Talk to your Pharmacist or your PN Home Care Provider to ensure that the administration set provided with your prescription containing CLINOLEIC 20% includes a 1.2 micron filter to reduce the risk of particles entering the tubing.

For any questions regarding the use of filters, please contact your Health Care Professional or Home Care Provider.

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing side effects are generally presumed to underestimate the risks associated with health product treatments. Any case of serious or unexpected side effects in patients receiving CLINOLEIC 20% should be reported to Baxter Corporation or Health Canada.

Baxter Corporation

7125 Mississauga Rd, Mississauga, Ontario L5N 0C2

1-888-719-9955
canada_productsurveillance@baxter.com

You can report any suspected side effect associated with the use of health products to Health Canada by:

• Calling toll-free at 1-866-234-2345; or
  
   
• Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, please contact Health Canada at:

Health Product and Food Branch Inspectorate

E-mail: DCVIU_UVECM@hc-sc.gc.ca

Telephone: 1-800-267-9675

Fax: 613-946-5636

Sincerely,

original signed by

Phil Lynch

Director, Quality,

Baxter Corporation

Baxter and Clinoleic are Registered Trademarks of Baxter International Inc. 2013FCA13