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Clinimix 5% TRAVASOL Amino Acid Injection - Expanded Recall to Include Four Additional Products/Lots due to Particulate Matter Found in the Solution - Notice to Hospitals
- Starting date:
- May 29, 2014
- Posting date:
- May 29, 2014
- Type of communication:
- Notice to Hospitals
- Subcategory:
- Drugs
- Source of recall:
- Health Canada
- Issue:
- Contamination
- Audience:
- Healthcare Professionals
- Identification number:
- RA-39715
NOTICE TO HOSPITALS - Health Canada Endorsed Important Safety Information - Expanded Product Recall of Baxter Clinimix to Include Four additional Products/Lots
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: Expanded Product Recall of Baxter Clinimix to include Four Additional Products/Lots due to Particulate Matter Found in the Solution:
Clinimix 5% TRAVASOL Amino Acid Injection WITHOUT Electrolytes in 25% Dextrose Injection, 1L (DIN: 02013959) (Product Code: JB6760P, Lot Number: W3K11C3)
Clinimix 5% TRAVASOL Amino Acid Injection WITH Electrolytes in 20% Dextrose Injection, 1L (DIN: 02014068) (Product Code: JB6763P, Lot Number: W3J23C3)
Clinimix 5% TRAVASOL Amino Acid Injection WITH Electrolytes in 10% Dextrose Injection, 1L (DIN: 02014076) (Product Code: JB6767P, Lot Number: W3L11C2)
Clinimix 5% TRAVASOL Amino Acid Injection WITHOUT Electrolytes in 16.6% Dextrose Injection, 1L (DIN: 02046709) (Product Code: JB6770P, Lot Number: W3K13C2)
Baxter Corporation in consultation with Health Canada has initiated an Urgent Product Recall for four (4) additional Clinimix products due to particulate matter found in the solution. The four (4) affected lots (Lot Numbers: W3K11C3, W3J23C3, W3L11C2 and W3K13C2) have been distributed in Canada between November 01, 2013 and March 27, 2014.
Clinimix products are sterile, hypertonic, non-pyrogenic solutions of essential and non-essential amino acids presented with or without electrolytes, for intravenous administration.
- There is potential for particulate matter to be present in Clinimix products.
- 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.
Please note a Notice to Hospitals was also posted on April 17, 2014 for Clinimix - 5% TRAVASOL Amino Acid Injection WITH Electrolytes in 16.6% Dextrose Injection, 1L.
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 products 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, 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 products, (Lot Numbers: W3K11C3, W3J23C3, W3L11C2 and W3K13C2), please contact Baxter Customer Care at 1-888-719-9955.
Sincerely,
original signed by
Danielle Tokarski
Quality Systems Manager
Baxter Corporation