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Methotrexate Sodium Injection 25 mg/mL (2mL) - Recall Due to Possible Presence of Cracked Vials - For the Public

Starting date:
December 18, 2013
Posting date:
December 18, 2013
Type of communication:
Public Communication
Source of recall:
Health Canada
Important Safety Information
General Public
Identification number:

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

Public Communication - Health Canada Endorsed Important Safety Information on METHOTREXATE SODIUM INJECTION 25 mg/mL (2mL) - DIN 02099705 - Lots 12J30KK, 12J30KH, 12J30KB

December 18, 2013
Subject: Recall of METHOTREXATE SODIUM INJECTION 25 mg/mL (2mL) DIN 02099705 – Distributed by Teva Canada Limited (formerly Novopharm Limited) Lots 12J30KK, 12J30KH, 12J30KB due to possible cracks in glass container
Teva Canada Limited, in consultation with Health Canada, is initiating a voluntary recall of 3 lots (listed above) of METHOTREXATE SODIUM INJECTION 25mg/mL (2mL) due to the possibility of cracks in the glass containers. This medication may be used in the treatment of cancer, psoriasis and arthritis related conditions. 
Although this Product is used in hospitals and in cancer clinics, Health Canada has advised that there may be instances where it could be used by doctors in their office or by a patient in their own home.
  • The 3 lot numbers (listed above) of Methotrexate Sodium Injection 25 mg/mL (2 mL) are being recalled due to the potential for cracks in the neck area of the glass container.  A crack in the glass container could compromise the sterility of the contents of the container and pose a risk of infection if the medication is used.
  • If you are receiving treatment using METHOTREXATE SODIUM INJECTION you are advised to contact your doctor if you have any concerns.
  • If you have any containers of METHOTREXATE SODIUM INJECTION 25mg/mL (2mL) with the lot numbers 12J30KK and/or 12J30KH and/or 12J30KB, please do not use them. Contact your doctor and the pharmacy or hospital where you got the medication. Please ensure you get replacement medication in order to complete your scheduled therapy.
This recall does not affect any other lots of METHOTREXATE SODIUM INJECTION supplied by Teva Canada.
This Public Communication is not intended as medical advice. In order to understand the implications of this information to your health and before you modify the way you use this health product, it is important that you consult your doctor or health care professional. 
Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of unexpected side effects in patients receiving METHOTREXATE SODIUM INJECTION 25mg/mL (2mL) should be reported to Teva Canada or Health Canada.

Medical Affairs Department
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
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 (HPFBI)
Telephone: 1-800-267-9675
Fax: 1-613-946-5636

original signed by

Paul Stojanovski
Vice President, Quality and Compliance
Teva Canada Limited