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Baxter Nitroglycerin 100 mg in 5% Dextrose Solution - Product Recall due to Particulate Matter Found in the Solution - Notice to Hospitals

Starting date:
October 11, 2013
Posting date:
October 15, 2013
Type of communication:
Notice to Hospitals
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Contamination, Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-36253

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 Nitroglycerin 100 mg in 5% Dextrose Solution 

Oct 11, 2013

Dear Chief of Medical Staff and Director of Pharmacy,

Please distribute to relevant Departments of Surgery, Emergency Medicine, Paediatrics, Anaesthesia, Geriatrics, Internal Medicine, Nursing, Dentistry, Intensive Care, Cardiac Care Unit, Pharmacy 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 Nitroglycerin 100 mg in 5% Dextrose Solution (DIN: 02145316) Due to Particulate Matter Found in the Solution (Product Code: JA0696, Lot Number: G103358)

Baxter Corporation in consultation with Health Canada has initiated a voluntary recall for one lot of Nitroglycerin 100 mg in 5% Dextrose Solution due to particulate matter found in the solution. The affected lot has been distributed in Canada between September 2012 and May 2013.

Nitroglycerin in 5% Dextrose product is for intravenous use only for treatment of peri-operative hypertension, for control of congestive heart failure in the setting of acute myocardial infarction and for the treatment of angina pectoris.  

  • There is potential for particulate matter to be present in Nitroglycerin 100 mg in 5% Dextrose solution.
  • If infused, particulate matter could potentially lead to patient harm including venous and/or arterial thrombo-embolism and death. 
  • Baxter is advising all users to immediately locate and remove the affected lot from use.  Return all affected inventory to Baxter.

The root cause for this issue has been identified and resolved.  Contact Baxter Customer Care to arrange for return and credit of the affected lot number 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 Nitroglycerin in 5% Dextrose should be reported to Baxter Canada or Health Canada.

You can report any suspected adverse reactions associated with the use of Baxter health products to Baxter Corporation by: 
Phone: 1-800-387-8399 ext 6607
E-Mail: canada_pharmacovigilance@baxter.com
Fax: 1-855-767-4573
Mailing address:
Attn: Pharmacovigilance
Baxter Corporation
7125 Mississauga Road
Mississauga, ON
L5N 0C2

For questions related to the return of affected Nitroglycerin 100 mg in 5% Dextrose Solution Product Code: JA0696, Lot Number: G103358, please 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

Sincerely, 

Original signed by

Phil Lynch
Director, Quality,
Baxter Corporation