Clinimix - 5% TRAVASOL Amino Acid Injection WITH Electrolytes in 16.6% Dextrose Injection, 1 L - Recall Due to Particulate Matter Found in the Solution - Notice to Hospitals

Starting date:

April 17, 2014

Posting date:

April 17, 2014

Type of communication:

Notice to Hospitals

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Contamination

Audience:

Healthcare Professionals

Identification number:

RA-39171

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

Notice about Health Canada advisories

NOTICE TO HOSPITALS - Health Canada Endorsed Important Safety Information on Clinimix - 5% TRAVASOL Amino Acid Injection WITH Electrolytes in 16.6% Dextrose Injection, 1L

April 17, 2014

Dear Chief of Medical Staff and Director of Pharmacy,

Please distribute to relevant Departments of Surgery, Pharmacy, Emergency Medicine, Paediatrics, Anaesthesia, Geriatrics, Internal Medicine, Nursing, Intensive Care, and/or other Departments as required, and other involved professional staff and post this notice in relevant areas in your institution.

Subject: Product Recall For Baxter Clinimix 5% TRAVASOL Amino Acid Injection WITH Electrolytes in 16.6% Dextrose Injection, 1 L (DIN: 02013967) due to Particulate Matter Found in the Solution (Product Code: JB6771P, Lot Numbers: W3K07C2, W3L04C2, W3L04C2S).                 

Baxter Corporation in consultation with Health Canada has initiated an Urgent Product Recall for Clinimix 5% TRAVASOL Amino Acid Injection WITH Electrolytes in 16.6% Dextrose Injection, 1 L due to particulate matter found in the solution. The three (3) affected lots (Lot Numbers: W3K07C2, W3L04C2, W3L04C2S) have been distributed in Canada between November 19, 2013 and March 24, 2014.

Clinimix 5% TRAVASOL Amino Acid Injection WITH Electrolytes in 16.6% Dextrose Injection, 1 L, is a sterile, hypertonic, non-pyrogenic solution of essential and non-essential amino acids presented with electrolytes, for intravenous administration.

• There is potential for particulate matter to be present in Clinimix 5% TRAVASOL Amino Acid Injection WITH Electrolytes in 16.6% Dextrose Injection, 1 L.
• If infused, particulate matter could potentially lead to patient harm including phlebitis and, thrombo-embolism, which could result in death.
• Baxter is advising all users to immediately locate and remove the affected lots from use. Return all affected inventory to Baxter.

Contact Baxter Customer Care to arrange for return and credit of the affected lot numbers at 1-888-719-9955. 

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-market adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse reactions in patients receiving Clinimix 5% TRAVASOL Amino Acid Injection WITH Electrolytes in 16.6% Dextrose Injection, 1 L, should be reported to Baxter Corporation or Health Canada.

Mailing address:
Attn: Pharmacovigilance
Baxter Corporation
7125 Mississauga Road
Mississauga, ON
L5N 0C2
Phone: 1-800-387-8399 ext 6607
E-Mail: canada_pharmacovigilance@baxter.com
Fax: 1-855-767-4573

To correct your mailing address or fax number, contact Baxter Customer Care at 1-888-719-9955.

You can report any suspected adverse reactions 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 Products and Food Branch Inspectorate
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 613-946-5636

For questions related to the return of affected Clinimix 5% TRAVASOL Amino Acid Injection WITH Electrolytes in 16.6% Dextrose Injection, 1 L, (Product Code: JB6771P, Lot Numbers: W3K07C2, W3L04C2, W3L04C2S), please contact Baxter Customer Care at 1-888-719-9955.

Sincerely,

original signed by

Danielle Tokarski
Quality Systems Manager
Baxter Corporation