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Infanrix Hexa - Voluntary Recall of Vaccine Due to Potential Microbiological Contamination - For the Public

Starting date:
November 2, 2012
Posting date:
November 2, 2012
Type of communication:
Public Communication
Subcategory:
Drugs, Biologic/vaccine, Affects children, pregnant or breast feeding women, Affects children, pregnant or breast feeding women, Specialized Products
Source of recall:
Health Canada
Audience:
General Public, Healthcare Professionals
Identification number:
RA-15834

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

Public Communication - Health Canada Endorsed Important Safety Information on Infanrix Hexa

November 2, 2012

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

GlaxoSmithKline, in consultation with Health Canada, would like to inform you of its decision to voluntarily recall one Lot (A21CB242A) of Infanrix Hexa® vaccine as a result of detection of contamination in the environment where material used to make the recalled vaccine had been placed. No contamination was found in the vaccine.

  • The recall is a precautionary measure.
  • No contamination has been found in the vaccine.
  • No reported adverse events appear to be linked to the reasons for the recall.

Infanrix Hexa® is a vaccine used in children for protection against diphtheria, tetanus (lockjaw), pertussis (whooping cough), hepatitis B, poliomyelitis (polio) and Haemophilus influenzae type b diseases. Vaccination is the best way to protect against these diseases.

Infanrix Hexa® is only currently offered through vaccination programs in British Columbia and the Yukon Territory.

Recent investigations detected contamination in the environment where one of the components of this Lot was placed.

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

GlaxoSmithKline has sent a letter to healthcare professionals informing them about this recall.  This information may be obtained on the Canadian web site of GlaxoSmithKline or on the Health Canada Web site.

Should you have any questions or require additional information regarding the use of Infanrix Hexa® please contact your healthcare professional.

For media inquiries, please contact GlaxoSmithKline Communications at (905) 819-3363.

GSK sincerely apologizes for this situation and is working closely with health authorities to prevent any impact on children's immunization schedule.

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 your local health department at the following addresses:

GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Phone: 1-800-387-7374

How to report a suspected Adverse Event following Immunization:
Should you experience an adverse event following immunization, please ask your doctor, nurse, or pharmacist to complete the Adverse Events following Immunization (AEFI) Form.

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

Sincerely,

original signed by

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