This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Health professional risk communication

BUSULFEX (busulfan) 6 mg/mL Injection - Potential for Particulate Matter in 10 mL vials - Notice to Hospitals

Starting date:
April 7, 2014
Posting date:
April 7, 2014
Type of communication:
Notice to Hospitals
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Contamination
Audience:
Healthcare Professionals
Identification number:
RA-38885

This is duplicated text of a letter from Otsuka Canada Pharmaceutical Inc. 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 BUSULFEX (busulfan) 6 mg/mL Injection

April 7, 2014

Dear Health Care Professional,

Please distribute to relevant Departments (Bone Marrow Transplant Center, Oncology, Hematology, Paediatrics, Pharmacy, Internal Medicine and Nursing) and other involved professional staff and post this notice in all relevant areas of your institution.

Subject: Potential for Particulate Matter in 10 mL vials of BUSULFEX® (busulfan) 6 mg/mL Injection (DIN 02240602)

Otsuka Canada Pharmaceutical Inc. in consultation with Health Canada would like to inform you of a potential risk of black particulate matter in vials of BUSULFEX® (busulfan) 6 mg/mL Injection. Black particulate matter has been found in one vial of BUSULFEX® (busulfan) distributed in the European Union market. The black particulate matter has been identified to be of silicone and stainless steel composition. The likely root cause has been identified and corrected. Although there have been no reported complaints for BUSULFEX® (busulfan) lots that have been distributed in Canada , there is a potential that BUSULFEX® (busulfan) lots on the Canadian market could be affected.

  • Carefully inspect BUSULFEX® (busulfan) prior to use for the presence of visible particulate matter. Do not administer if black particulate or any particulate matter is observed in a vial as there is a potential risk that particulate matter introduced into the blood stream may result in patient injury, such as local inflammation, phlebitis, allergic response, and/or an embolic event.
  • Follow all recommended steps in the product monograph1 for dilution and administration of BUSULFEX® (busulfan). As a precautionary measure and consistent with standard practice, the diluted product is to be administered through an infusion set including an in-line filter (as per your internal protocol, and generally between 0.2 – 1.2 µm). Do not use polycarbonate syringes or polycarbonate filter needles with BUSULFEX® (busulfan).
  • In the event any particulate matter is noted upon inspection, please contact Otsuka Canada Pharmaceutical Inc. at 1-877-341-9245 immediately. Instructions for returning the affected vial(s) will be provided and a replacement vial(s) will be sent to you.

BUSULFEX® (busulfan) Injection is indicated for use in combination with other chemotherapeutic agents and/or radiotherapy as a conditioning regimen prior to hematopoietic progenitor cell transplantation, including: acute lymphocytic leukemia, acute non-lymphocytic leukemia, acute myeloid leukemia, chronic myeloid leukemia, non-Hodgkin’s lymphoma, Hodgkin’s disease, multiple myeloma, and myelodysplastic syndrome.1

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 particulate matter or other serious or unexpected adverse reactions in patients receiving BUSULFEX® (busulfan) 6 mg/mL Injection should be reported to Otsuka Canada Pharmaceutical Inc. or Health Canada.

Otsuka Canada Pharmaceutical Inc.
2250 Alfred Nobel Boulevard, Suite 301
Saint-Laurent, Quebec
H4S 2C9
Phone: 1-877-341-9245
Fax: 1-905-689-1465

To correct your mailing address or fax number, contact Otsuka Canada Pharmaceutical Inc.

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
Phone: 1-800-267-9675
Fax: 1-613-946-5636

To report any product quality complaints, or should you have any questions or need additional information about BUSULFEX® (busulfan), please contact Otsuka Canada Pharmaceutical Inc. Medical Information at 1-877-341-9245.

Otsuka is committed to the highest ethical and safety standards and continues to monitor BUSULFEX® product complaints worldwide.

Sincerely,

original signed by

Otsuka Canada Pharmaceutical Inc.
Per:
Khalid Mezzi, MD, MBA
Director, Medical Affairs

Reference:

1  BUSULFEX® (busulfan) [product monograph]. Saint-Laurent, Quebec: Otsuka Canada Pharmaceutical Inc.; January 2012.