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Health professional risk communication

Infanrix Hexa - Voluntary Recall of Vaccine Due to Potential Microbiological Contamination - For Health Professionals

Starting date:
October 30, 2012
Posting date:
November 2, 2012
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Biologic/vaccine
Source of recall:
Health Canada
Audience:
Healthcare Professionals
Identification number:
RA-15833

This is duplicated text of a letter from GlaxoSmithKline Inc.
Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on Infanrix Hexa

October 30, 2012

Dear Health Care Professional:

Subject: Voluntary recall of GlaxoSmithKline (GSK) Infanrix Hexa® Vaccine Lot A21CB242A due to potential microbiological contamination

GlaxoSmithKline, in consultation with Health Canada, would like to inform you of the decision to voluntarily recall one Lot (A21CB242A) of Infanrix Hexa® vaccine as a result of potential microbial contamination.

  • The recall is a precautionary measure due to potential microbial contamination
  • Do not administer doses from the affected lot
  • No contamination has been found in the final product released for distribution.
  • No reported spontaneous adverse events appear to be linked to the reasons for the recall.

Infanrix Hexa® is indicated for active primary immunization against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and disease caused by Haemophilus influenzae type b in infants and children 6 weeks to 2 years, and is presented as a sterile suspension for injection, DIN 2253852.

Infanrix Hexa® is only currently offered in a Universal Mass Vaccination (UMV) program in British Columbia and Yukon.

Recent investigations identified the potential for microbiological contamination in the environment where vaccine bulk antigens for Infanrix Hexa®, Infanrix™-IPV and Infanrix™- IPV/Hib vaccines were placed. The release tests (including sterility tests) on intermediates and on the final containers met pre-established acceptance criteria. No contamination was found in the final product released for distribution.

A search of the GSK worldwide safety database did not identify any reported spontaneous adverse events that appear to be linked to microbial contamination. GSK has decided to initiate a voluntary recall of the abovementioned Lot as a precautionary measure.

Actions Requested of Healthcare Professionals

  1. Do not administer doses from the affected lot
    • Please quarantine and do not administer any unused doses of the affected Lot of Infanrix-Hexa®.
    • Please follow the local procedures for the return receipt of these doses.
  2. Post-immunisation patient follow-up
    • Patients to whom doses from the affected Lot have been already been administered should be monitored as per routine post-immunisation practice.
    • Please report any Adverse Events following Immunisation as detailed below.

GSK sincerely apologizes for this unforeseen situation and will work closely with providers and authorities to minimize any disruption to delivery of the childhood immunization program in Canada.

Managing marketed health product-related adverse events depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse events are generally presumed to underestimate the risks associated with health product treatments. Any case of serious or unexpected adverse events in patients receiving Infanrix Hexa® should be reported to GSK or the Public Health Agency of Canada at the following addresses:

GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Phone:  1-800-387-7374 (option 3 for GSK Medical Information)

To correct your mailing address or fax number, contact GlaxoSmithKline Inc.

How to report a suspected Adverse Event following Immunization:
If a patient experiences an adverse event following immunization, please complete the Adverse Events Following Immunization (AEFI) Form and send it to the local health department in your province or territory.

The Adverse Events Following Immunization Reporting Form and Guidelines can be found on the Public Health Agency of Canada Web site or in the Canadian Compendium of Pharmaceuticals and Specialties.

If you have any questions or have difficulties contacting your local health department, please contact the Vaccine Safety Section at the Public Health Agency of Canada at:
Telephone: 613-954-5590, 1-866-844-0018
Fax: 613-954-9874; 1-866-844-5931

Should you have any questions or require additional information regarding the use of Infanrix Hexa® please contact GlaxoSmithKline Inc., Medical Information Department at 1-800-387-7374 (option 3).

Sincerely,

original signed by

Dr. Glenn Crater
Vice President, Medical and Chief Medical Officer
GlaxoSmithKline Inc.