GSK recalls two lots of migraine medication: IMITREX Injection

Starting date:
November 1, 2013
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Identification number:
RA-36603

Issue

GlaxoSmithKline Inc., in consultation with Health Canada, is voluntarily recalling two lots of “IMITREX Injection”, a migraine medication packaged in pre-filled syringes with an accompanying sterile needle for injection. The needles come with plastic shields that are designed to keep them free of contamination. Needles in the affected lots may be protruding through the needle shield.

The protruding needle is no longer sterile and as such, there is a potential risk of infection to consumers when using the product.

Products affected

  1. IMITREX Injection, DIN 02212188 (Lot numbers: C637078, C632842)

What you should do

  • Patients who have IMITREX injection from the affected lots should not use the product, and should return it to their pharmacist.
  • If you have used IMITREX injection in the past three months, contact your healthcare professional.
  • Report any adverse events using this product to Health Canada.
  • Contact GSK Inc. at 1-800-387-7374 for more information about returning the product.

Who is affected

Consumers who have used or are using any product from the two affected lots (see above).

Report health or safety concerns

  • Call toll-free at 1-866-234-2345
  • Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Media enquiries

Media Enquiries:
Health Canada
(613) 957-2983

Public enquiries

Public Enquiries:
(613) 957-2991
1-866 225-0709

What Health Canada is doing

Health Canada is monitoring the recall of “IMITREX Injection” by GSK.

For more information

Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.