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0.9% Sodium Chloride Injection USP and 5% Dextrose Injection USP - Recalled Lot Due to the Potential for Leakage of the Parenteral Solution Bag

Report a Concern
Starting date:
March 4, 2015
Posting date:
March 4, 2015
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Hospitals
Identification number:
RA-52431

   

This is duplicated text of a letter from the Baxter Corporation prepared in collaboration with Health Canada.

Audience

Health Care Professionals working in the following settings: Hospitals, Pharmacy, Nursing, Surgery, Emergency departments, Long term care facilities, Clinics, Dentistry, Homecare nursing and other relevant areas.

Key messages

  • Baxter is recalling one (1) lot of 0.9% Sodium Chloride Injection USP, 50 mL and one (1) lot of 5% Dextrose Injection USP, 50 mL due to the potential for leakage of the parenteral solution bag.
  • Leakage of a parenteral solution bag may result in delay or interruption of therapy, microbial contamination, and air in the system. If used in IV admixture, there is potential for delivery of a more concentrated drug solution than intended.
  • Baxter is advising all users to immediately locate and remove the affected lots from use and return all affected inventory to Baxter Corporation. The affected lots should not be used.

   

Issue

Baxter has initiated a recall of one (1) lot of 0.9% Sodium Chloride Injection USP, 50 mL and one (1) lot of 5% Dextrose Injection USP, 50 mL due to potential leakage of the parenteral solution bag. Leakage of parenteral solution bags may result in patient harm or adverse health consequences including blood stream infection and air embolism.

These lots were distributed in Canada between April 02, 2014 and August 07, 2014.

Products affected

The products impacted are:

Product name DIN Package format Lot number Expiry date
0.9% Sodium Chloride Injection USP 00060208 50 mL P313684 August 31, 2015
5% Dextrose Injection USP 00060348 50 mL P313031 July 31, 2015

Background information

0.9% Sodium Chloride Injection USP is indicated as a source of water and electrolytes and 5% Dextrose Injection USP is indicated as a source of water and calories.

Baxter received complaints for leakage of the parenteral solution bag of both specified lots; but has not received any reports of adverse events. The root cause was determined to be a malfunction of one component of the bag making/sealing equipment. Baxter has resolved the issue and product currently being shipped is not affected.

Who is affected

Information for consumers

Patients who have affected lots in their homes should not use the affected lots and notify their Health Care Professional.

Consumers should contact their Health Care Professional for more information.

Information for health care professionals

The specified solution lots should not be used. Contact Baxter Customer Care to arrange for return and credit of the affected lot numbers at 1-888-719-9955.

Health Care Professionals should also notify affiliated staff administering this product in a homecare setting.

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 of serious blood infection or air embolism or other serious or unexpected side effects in patients receiving 0.9% Sodium Chloride Injection USP, 50 mL or 5% Dextrose Injection USP, 50 mL 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 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 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
Quality Systems Manager
Baxter Corporation

For more information

The manufacturer advised Health Canada of the risk associated with this health product, and has recalled the impacted 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.