TORONTO, Dec. 18, 2013 /CNW/ -
Recall of METHOTREXATE SODIUM INJECTION 25 mg/mL (2mL)
DIN 02099705 - Distributed by Teva Canada Limited (formerly Novopharm
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)
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
You can report any suspected adverse reactions associated with the use
of health products to Health Canada by:
For other health product inquiries related to this communication,
contact Health Canada at:
Lead Directorate: Health Products and Food Branch Inspectorate (HPFBI)
"Original signed by"
Vice President, Quality and Compliance
Teva Canada Limited
SOURCE: Teva Canada Limited
For further information:
Vice-President, Corporate Communications - Americas