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Recall of 3 batches of Teva-brand Methotrexate Sodium Injection 25 mg/mL (2mL)

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

Re: Limited Recall of TEVA-brand Methotrexate Sodium injection (see below)

IMPLICATIONS FOR PATIENTS AND PRESCRIBERS OF INJECTABLE METHOTREXATE

Teva is only one brand of methotrexate.  Though the TEVA brand is distributed across Canada it only represents 15% of the market. Thus 85% of patients are not using Teva-brand methotrexate and this announcement DOES NOT apply to them.

Of those using Teva brand, only 3 batches are affected, thus most patients are not affected. They should confirm with their pharmacist whether their current vials are from the batches noted below.  All other providers and all other batches of TEVA-brand Methotrexate are not included in this recall.

Patients who have been prescribed methotrexate by injection, but whose medication does not come from the impacted lot numbers, should feel confident that they can continue to receive treatment in safety. Patients are cautioned that discontinuing the prescribed course of treatment with this medication can have serious consequences, up to and including relapse. Anyone with arthritis who is uncertain about whether they should continue to take their prescribed methotrexate injections is encouraged to contact their rheumatologist, family physician or pharmacist.


 

12/18/2013

Dear Health Care Professional;

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 presence of cracked vials

Teva Canada Limited, in consultation with Health Canada, is initiating a voluntary recall to the patient level
for 3 lots (listed above) of Methotrexate Sodium Injection 25 mg/mL (2 mL) DIN 02099705, due to the
possible presence of some cracked vials in these lots. Sterility of the contents of cracked vials could be
compromised.

Teva Canada Limited has received two reports of vial breakage upon removal of the Product’s flip-off cap. As the Product is packaged in glass vials, the potential exists that some vials of the Product may be cracked at the neck of the vial.

Methotrexate Sodium Injection is a medication used in the treatment of neoplastic disease and may also
be used as a disease modifying antirheumatic drug (DMARD). The Product may be administered by the
intravenous, intramuscular, intra-arterial or intrathecal routes.

Although this Product is used in the hospital and/or oncology clinic setting, Health Canada has advised that there may be instances where it could be used by physicians in their office or by a patient in their home.

  • There is a possibility of the presence of some cracked vials in 3 lots of Methotrexate Sodium Injection
  • 25 mg/mL (2 mL). Sterility of the contents of the cracked vials could be compromised.
  • Healthcare Professionals should be vigilant of any unusual, or infection related patient symptoms.
  • Please examine your inventory and determine if you have any remaining stock of the above mentioned lots of the Product. Stop distributing and quarantine the above mentioned lots of the Product. If you distributed the Products to another practitioner or other supply chain participant, please notify them to cease distribution
  • Please review your records and determine if you have provided the above mentioned Products to any of your patients. If you provided Product to a patient, please advise them of the recall and recover any remaining units for return. It is important that you replace the returned vials of Product to ensure completion of their therapy within the prescribed time period. If necessary, please contact Teva Canada Customer Care regarding additional supply of this Product for your patient. (See contact information below.)
  • Please return all Products to your point of purchase.
  • No other lots of the Product are affected by this recall.

If you have any specific questions regarding the recall process, please contact Teva Canada Customer
Care at 1-800-268-4129.

Managing marketed health product-related adverse reactions depends on Health Care Professionals and
consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-
marketing adverse reactions are generally presumed to underestimate the risks associated with health
product treatments. Any case of serious or unexpected adverse reactions in patients receiving
Methotrexate Sodium Injection 25 mg/mL (2mL) from Lots 12J30KK, 12J30KH, 12J30KB should be
reported to Teva Canada Limited or Health Canada.

Teva Canada Limited
30 Novopharm Court
Toronto ,Ontario
M1B 2K9
1-800-268-4129

To correct your mailing address or fax number, contact Teva Canada Limited.

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 (
http://www.hc-sc.gc.ca/dhpmps/
medeff/report-declaration/index-eng.php) 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:
Lead Directorate: Health Products and Food Branch Inspectorate (HPFBI)
E-mail:
DCVIU_UVECM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 1-613-946-5636

Teva Canada would like to thank you for your understanding and continued support.
Sincerely,


Paul Stojanovski
Vice President, Quality and Compliance
Teva Canada Limited

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