Baxter CLINIMIX, 5% Travasol Amino Acid Injection WITHOUT Electrolytes in 16.6% Dextrose Injection 1 L - Recall Due to Particulate Matter Found in Solution

Starting date:
June 20, 2015
Posting date:
June 20, 2015
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Contamination, Microbial Hazard, Suspected quality concern
Audience:
Healthcare Professionals
Identification number:
RA-53902

Audience

Health Care Professionals working in the following settings: Hospitals, Pharmacy, Nursing, Surgery, Emergency departments, Intensive Care, Anaesthesia, Geriatrics, Pediatrics, Internal Medicine, Long term care facilities and other relevant areas.

Key messages

  • Baxter Corporation has initiated an Urgent Product Recall for three (3) lots (Lot Numbers: W4J03C2, W4J14C1 and W4J14C1S) of CLINIMIX, 5% Travasol Amino Acid Injection WITHOUT Electrolytes in 16.6% Dextrose Injection 1L due to particulate matter found in the solution.
  • 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. The affected lots should not be used and all affected inventory returned to Baxter.
                       

Issue

Baxter has initiated a recall for three (3) lots (Lot Numbers: W4J03C2, W4J14C1 and W4J14C1S) of CLINIMIX, 5% Travasol Amino Acid Injection WITHOUT Electrolytes in 16.6% Dextrose Injection 1L due to product complaints for particulate matter found in the solution. If infused, particulate matter could potentially lead to patient harm including phlebitis and thrombo-embolism, which could result in death. Affected lots were distributed in Canada between October 10, 2014 and May 26, 2015.

Products affected
Product name DIN Package format Product Code Lot number Expiry date
CLINIMIX - 5% Travasol Amino Acid Injection WITHOUT Electrolytes in 16.6% Dextrose Injection 02046709 1L JB6770P W4J03C2
W4J14C1
W4J14C1S
31OCT2015

Background information

CLINIMIX (Amino Acids without Electrolytes in Dextrose Injection) products are indicated as a source of amino acids and carbohydrate calories in clinical conditions where enteral nutritional supply is or is expected to be insufficient or impossible in order to offset or prevent nitrogen loss or negative nitrogen balance.

Baxter has received complaints for particulate matter in solution; but has not received any reports of adverse events. The root cause of this issue is currently under investigation. Baxter has identified the source of the particulate matter to be polyvinyl chloride (PVC) plastic from the internal bag port. Products currently being shipped are not affected.

Who is affected

Information for consumers

Consumers should contact their Health Care Professional for more information.

Information for health care professionals

The affected lots of Clinimix solution should not be used and should be returned as outlined in the Recall Notice issued by Baxter Corporation.

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

Please inform other health care professionals in your organization of this recall notification. If your institution or pharmacy has distributed the affected product lots further, notify recipients that they may have received the product lots identified above and ask them to return the affected product as indicated in the Recall Notice.

Action taken by Health Canada

Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication will be further distributed through the MedEffect™ e-Notice email notification system. Health Canada is also monitoring the recall and the implementation of necessary corrective and preventive actions.

Report health or safety concerns

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case phlebitis, thrombo-embolism or other serious or unexpected side effects in patients receiving CLINIMIX 5% Travasol Amino Acid Injection WITHOUT Electrolytes in 16.6% Dextrose Injection should be reported to Baxter Corporation or Health Canada.

Baxter Corporation
Attn: Pharmacovigilance
7125 Mississauga Road
Mississauga, ON, L5N 0C2
To report an Adverse Reaction, health professionals and consumers may call toll free:
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 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: 1-613-946-5636

Sincerely,

Original signed by

Danielle Tokarski
Sr. Quality Systems Manager
Baxter Corporation

Clinimix (2015-06-19)

2015-06-19 | Health products

Recall

For more information

The manufacturer advised Health Canada of the risk associated with this health product. Health Canada supports the actions taken by the manufacturer and as such a risk assessment was not required and a Summary Safety Review was not prepared.